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NDC 00143-9298-10 Sodium Ferric Gluconate Complex in Sucrose 12.5 mg/mL Details
Sodium Ferric Gluconate Complex in Sucrose 12.5 mg/mL
Sodium Ferric Gluconate Complex in Sucrose is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is SODIUM FERRIC GLUCONATE COMPLEX.
MedlinePlus Drug Summary
Sodium ferric gluconate injection is used to treat iron-deficiency anemia (a lower than normal number of red blood cells due to too little iron) in adults and children 6 years of age and older with chronic kidney disease (damage to the kidneys which may worsen over time and may cause the kidneys to stop working) who are on dialysis and are also receiving the medication epoetin (Epogen, Procrit). Sodium ferric gluconate injection is in a class of medications called iron replacement products. It works by replenishing iron stores so that the body can make more red blood cells.
Related Packages: 00143-9298-10Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Sodium Ferric Gluconate Injection
Product Information
NDC | 00143-9298 |
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Product ID | 0143-9298_4272216c-1e53-4180-a731-0592e772666f |
Associated GPIs | 82300085102020 |
GCN Sequence Number | 067223 |
GCN Sequence Number Description | sodium ferric gluconat/sucrose VIAL 62.5MG/5ML INTRAVEN |
HIC3 | C3B |
HIC3 Description | IRON REPLACEMENT |
GCN | 29727 |
HICL Sequence Number | 019948 |
HICL Sequence Number Description | SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE |
Brand/Generic | Generic |
Proprietary Name | Sodium Ferric Gluconate Complex in Sucrose |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Sodium Ferric Gluconate Complex in Sucrose |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION |
Route | INTRAVENOUS |
Active Ingredient Strength | 12.5 |
Active Ingredient Units | mg/mL |
Substance Name | SODIUM FERRIC GLUCONATE COMPLEX |
Labeler Name | Hikma Pharmaceuticals USA Inc. |
Pharmaceutical Class | Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA] |
DEA Schedule | n/a |
Marketing Category | ANDA |
Application Number | ANDA078215 |
Listing Certified Through | 2024-12-31 |
Package
NDC 00143-9298-10 (00143929810)
NDC Package Code | 0143-9298-10 |
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Billing NDC | 00143929810 |
Package | 10 VIAL, SINGLE-DOSE in 1 CARTON (0143-9298-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0143-9298-01) |
Marketing Start Date | 2011-03-31 |
NDC Exclude Flag | N |
Pricing Information | N/A |