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AURYXIA 210 MG TAB 200

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Product Properties:

Description -
Description -
Description -
DESI Drug Ind -
DESI Drug Ind -
DESI Drug Ind -
DESI2 Drug Ind NR
DESI2 Drug Ind NR
DESI2 Drug Ind -
Drug Category S
Drug Category -
Drug Category -
Drug Type Code S
Drug Type Code S
Drug Type Code 1
FDA Approval Date 09/05/2014
FDA Approval Date 12/01/2014
FDA Approval Date 12/01/2014
FDA Therap Equiv TAB
FDA Therap Equiv TAB
FDA Therap Equiv NR
HCPCS -
HCPCS -
HCPCS -
Market Entry Date -
Market Entry Date -
Market Entry Date 12/01/2014
Medical Coverage -
Medical Coverage -
Medical Coverage -
Termination Date 1
Termination Date 1
Termination Date -
Unit TAB
Unit 200
Unit 200
Units Per Pkg 09/05/2014
Units Per Pkg 09/05/2014
Units Per Pkg 200
Active Ingredients 7462 ferric citrate 2338058
Active Ingredients 7462 ferric citrate 2338058
Active Ingredients 7462 ferric citrate 2338058
AHFS Class 40181900 PHOSPHATE-REMOVING AGENTS
AHFS Class 40181900 PHOSPHATE-REMOVING AGENTS
AHFS Class 40181900 PHOSPHATE-REMOVING AGENTS
DEA Class NC
DEA Class NC
DEA Class NC
Dose Form TABLET
Dose Form TABLET
Dose Form TABLET
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 72787 ferric citrate ORAL TABLET 210MG IRON
Gen Code and Des 72787 ferric citrate ORAL TABLET 210MG IRON
Gen Code and Des 72787 ferric citrate ORAL TABLET 210MG IRON
Inactive Ingredients 10138 blue dye; 10141 red dye; 10143 yellow dye
Inactive Ingredients 10138 blue dye; 10141 red dye; 10143 yellow dye
Inactive Ingredients 10138 blue dye; 10141 red dye; 10143 yellow dye
OMP Family -
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 210MG
Strength 210MG
Strength 210MG
Common Brand Name COMMON BRAND NAME(S): Auryxia, Ferric Citrate
Common Brand Name COMMON BRAND NAME(S): Auryxia, Ferric Citrate
Common Brand Name COMMON BRAND NAME(S): Auryxia, Ferric Citrate
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. This product can make it hard for your body to absorb many other drugs, including bisphosphonates (such as alendronate), certain quinolone antibiotics (such as ciprofloxacin), thyroid medications (such as levothyroxine), tetracycline antibiotics (such as doxycycline), among others. Separate your doses of these medications as far as possible from your doses of ferric citrate. Ask your doctor or pharmacist about how long you should wait between doses and for help finding a dosing schedule that will work with all your medications.
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. This product can make it hard for your body to absorb many other drugs, including bisphosphonates (such as alendronate), certain quinolone antibiotics (such as ciprofloxacin), thyroid medications (such as levothyroxine), tetracycline antibiotics (such as doxycycline), among others. Separate your doses of these medications as far as possible from your doses of ferric citrate. Ask your doctor or pharmacist about how long you should wait between doses and for help finding a dosing schedule that will work with all your medications.
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. This product can make it hard for your body to absorb many other drugs, including bisphosphonates (such as alendronate), certain quinolone antibiotics (such as ciprofloxacin), thyroid medications (such as levothyroxine), tetracycline antibiotics (such as doxycycline), among others. Separate your doses of these medications as far as possible from your doses of ferric citrate. Ask your doctor or pharmacist about how long you should wait between doses and for help finding a dosing schedule that will work with all your medications.
Allocation Period -
Allocation Period -
Allocation Period -
Case Quantity 12
Case Quantity 12
Case Quantity 12
Drug Form Pack Size 200
Drug Form Pack Size 200
Drug Form Pack Size 200
Form TABLET
Form TABLET
Form TABLET
Hazard Code -
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
NIOSH Code -
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Orange Book ZC Pharmaceutical entity and labeler evaluated but no therapeutic equivalence rating given. Usually applies to single source drugs.
Retail Pack Quantity 1
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Temp Zone 10 Room Temperature
Unit EA
Unit EA
Unit EA
Unit Size 200
Unit Size 200
Unit Size 200
How to Use HOW TO USE: See also Drug Interactions section. Take this medication by mouth, usually 3 times daily with a meal and some fluids as directed by your doctor. Do not lie down for at least 10 minutes after taking your dose. Swallow the tablets whole. Do not crush or chew the tablets. Crushing or chewing the tablets may cause your mouth or teeth to change color. Take this medication regularly to get the most benefit from it. The dosage is based on your medical condition, response to treatment, and lab test results. Do not take more of this medication than prescribed.
How to Use HOW TO USE: See also Drug Interactions section. Take this medication by mouth, usually 3 times daily with a meal and some fluids as directed by your doctor. Do not lie down for at least 10 minutes after taking your dose. Swallow the tablets whole. Do not crush or chew the tablets. Crushing or chewing the tablets may cause your mouth or teeth to change color. Take this medication regularly to get the most benefit from it. The dosage is based on your medical condition, response to treatment, and lab test results. Do not take more of this medication than prescribed.
How to Use HOW TO USE: See also Drug Interactions section. Take this medication by mouth, usually 3 times daily with a meal and some fluids as directed by your doctor. Do not lie down for at least 10 minutes after taking your dose. Swallow the tablets whole. Do not crush or chew the tablets. Crushing or chewing the tablets may cause your mouth or teeth to change color. Take this medication regularly to get the most benefit from it. The dosage is based on your medical condition, response to treatment, and lab test results. Do not take more of this medication than prescribed.
Missed Dose MISSED DOSE: If you miss a dose, skip the missed dose unless you have just eaten. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Missed Dose MISSED DOSE: If you miss a dose, skip the missed dose unless you have just eaten. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Missed Dose MISSED DOSE: If you miss a dose, skip the missed dose unless you have just eaten. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Your doctor may tell you to follow a special diet to help lower your blood phosphate levels. Follow the diet closely. Do not share this medication with others. Lab and/or medical tests (such as phosphate and iron blood levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Notes NOTES: Your doctor may tell you to follow a special diet to help lower your blood phosphate levels. Follow the diet closely. Do not share this medication with others. Lab and/or medical tests (such as phosphate and iron blood levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Notes NOTES: Your doctor may tell you to follow a special diet to help lower your blood phosphate levels. Follow the diet closely. Do not share this medication with others. Lab and/or medical tests (such as phosphate and iron blood levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Phonetic Pronunciation (FER-us SI-trate)
Phonetic Pronunciation (FER-us SI-trate)
Phonetic Pronunciation (FER-us SI-trate)
Precautions PRECAUTIONS: Before taking ferric citrate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal problems (such as ulcers, bleeding), high level of iron in the blood. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: Before taking ferric citrate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal problems (such as ulcers, bleeding), high level of iron in the blood. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Precautions PRECAUTIONS: Before taking ferric citrate, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal problems (such as ulcers, bleeding), high level of iron in the blood. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Nausea, diarrhea, constipation, or vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. The iron in this medication may cause your stools to turn black. This effect is harmless. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Side Effects SIDE EFFECTS: Nausea, diarrhea, constipation, or vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. The iron in this medication may cause your stools to turn black. This effect is harmless. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Side Effects SIDE EFFECTS: Nausea, diarrhea, constipation, or vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. The iron in this medication may cause your stools to turn black. This effect is harmless. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Storage STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Storage STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: Ferric citrate is used to lower high blood phosphate levels in people who are on dialysis due to severe kidney disease. Dialysis removes some phosphate from your blood, but it is difficult to remove enough to keep your phosphate levels balanced. Decreasing blood phosphate levels can help keep your bones strong, prevent unsafe buildup of minerals in your body, and may decrease the risk of heart disease and strokes that can result from high phosphate levels. This medication works by binding to phosphate in the foods you eat. The phosphate then passes out of your body in your stool. Ferric citrate is a form of iron. This medication is also used to treat low blood levels of iron (anemia) in people with long-term kidney disease who are not on dialysis. Iron is an important mineral that your body needs to produce red blood cells and keep you in good health.
Uses USES: Ferric citrate is used to lower high blood phosphate levels in people who are on dialysis due to severe kidney disease. Dialysis removes some phosphate from your blood, but it is difficult to remove enough to keep your phosphate levels balanced. Decreasing blood phosphate levels can help keep your bones strong, prevent unsafe buildup of minerals in your body, and may decrease the risk of heart disease and strokes that can result from high phosphate levels. This medication works by binding to phosphate in the foods you eat. The phosphate then passes out of your body in your stool. Ferric citrate is a form of iron. This medication is also used to treat low blood levels of iron (anemia) in people with long-term kidney disease who are not on dialysis. Iron is an important mineral that your body needs to produce red blood cells and keep you in good health.
Uses USES: Ferric citrate is used to lower high blood phosphate levels in people who are on dialysis due to severe kidney disease. Dialysis removes some phosphate from your blood, but it is difficult to remove enough to keep your phosphate levels balanced. Decreasing blood phosphate levels can help keep your bones strong, prevent unsafe buildup of minerals in your body, and may decrease the risk of heart disease and strokes that can result from high phosphate levels. This medication works by binding to phosphate in the foods you eat. The phosphate then passes out of your body in your stool. Ferric citrate is a form of iron. This medication is also used to treat low blood levels of iron (anemia) in people with long-term kidney disease who are not on dialysis. Iron is an important mineral that your body needs to produce red blood cells and keep you in good health.

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AURYXIA 210 MG TAB 200 is manufactured by KERYX BIOPHARMACEUTICALS, INC..
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