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NDC 00781-3154-01 Ferumoxytol 510 mg/17mL Details
Ferumoxytol 510 mg/17mL
Ferumoxytol is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Sandoz Inc. The primary component is FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE.
MedlinePlus Drug Summary
Ferumoxytol injection is used to treat iron-deficiency anemia (a lower than normal number of red blood cells due to too little iron) in adults with chronic kidney disease (damage to the kidneys which may worsen over time and may cause the kidneys to stop working). Ferumoxytol injection is used to treat iron-deficiency anemia in people who did not respond or are unable to tolerate taking iron preparations by mouth. Ferumoxytol 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: 00781-3154-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ferumoxytol Injection
Product Information
| NDC | 00781-3154 |
|---|---|
| Product ID | 0781-3154_d175dab8-4ddf-49e0-855a-5af1ac6dec2d |
| Associated GPIs | 82300068002020 |
| GCN Sequence Number | 065348 |
| GCN Sequence Number Description | ferumoxytol VIAL 510MG/17ML INTRAVEN |
| HIC3 | C3B |
| HIC3 Description | IRON REPLACEMENT |
| GCN | 26275 |
| HICL Sequence Number | 036439 |
| HICL Sequence Number Description | FERUMOXYTOL |
| Brand/Generic | Generic |
| Proprietary Name | Ferumoxytol |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ferumoxytol |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 510 |
| Active Ingredient Units | mg/17mL |
| Substance Name | FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE |
| Labeler Name | Sandoz Inc |
| Pharmaceutical Class | Iron [CS], Parenteral Iron Replacement [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA206604 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00781-3154-01 (00781315401)
| NDC Package Code | 0781-3154-01 |
|---|---|
| Billing NDC | 00781315401 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3154-01) / 17 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2021-07-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |