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NDC 00517-0602-01 Injectafer 50 mg/mL Details
Injectafer 50 mg/mL
Injectafer is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by American Regent, Inc.. The primary component is FERRIC CARBOXYMALTOSE.
MedlinePlus Drug Summary
Ferric carboxymaltose injection is used to treat iron-deficiency anemia (a lower than normal number of red blood cells due to too little iron) in adults who cannot tolerate or who could not successfully be treated with iron supplements taken by mouth. This medication is also used to treat iron deficiency anemia in adults with chronic kidney disease (damage to the kidneys which may worsen over time and may cause the kidneys to stop working) who are not on dialysis. Ferric carboxymaltose 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: 00517-0602-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ferric Carboxymaltose Injection
Product Information
| NDC | 00517-0602 |
|---|---|
| Product ID | 0517-0602_72f9297d-5eb4-4e10-9545-c4d6f686c2c5 |
| Associated GPIs | |
| GCN Sequence Number | 064151 |
| GCN Sequence Number Description | ferric carboxymaltose VIAL 100 MG/2ML INTRAVEN |
| HIC3 | C3B |
| HIC3 Description | IRON REPLACEMENT |
| GCN | 99857 |
| HICL Sequence Number | 035687 |
| HICL Sequence Number Description | FERRIC CARBOXYMALTOSE |
| Brand/Generic | Brand |
| Proprietary Name | Injectafer |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ferric Carboxymaltose Injection |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 50 |
| Active Ingredient Units | mg/mL |
| Substance Name | FERRIC CARBOXYMALTOSE |
| Labeler Name | American Regent, Inc. |
| Pharmaceutical Class | Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA203565 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00517-0602-01 (00517060201)
| NDC Package Code | 0517-0602-01 |
|---|---|
| Billing NDC | 00517060201 |
| Package | 1 VIAL, SINGLE-DOSE in 1 BOX (0517-0602-01) / 2 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2022-07-28 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |