Prescription drug · ANDA
Ferumoxytol NDC 0781-3154
Ferumoxytol non-stoichiometric magnetite 510 mg/17mL · Injection · Intravenous · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-3154-01 | 00781315401 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3154-01) / 17 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 15, 2021 | |
| 0781-3154-95 | 00781315495 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3154-95) / 17 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 15, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ferumoxytol
- Generic name (nonproprietary)
- ferumoxytol
- Active ingredients
- Ferumoxytol non-stoichiometric magnetite — 510 mg/17mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Sandoz Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206604
- Marketing start
- Listing expires
- Other FDA classes
- Iron (Chemical structure)
- Identifiers
- Product ID 0781-3154_27e854d4-45e9-4a2d-901e-bcf67303d57dSPL ID 27e854d4-45e9-4a2d-901e-bcf67303d57dSPL set ID cf94c7fc-13a0-4ac9-bb85-9c38aa704d35RxCUI 860605UNII CLH5FT6412
- Pharmacologic class
- Parenteral Iron Replacement
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400781315401followed by a unit qualifier and the quantityPackage 00781-3154-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Ferumoxytol is indicated for the treatment of iron deficiency anemia (IDA) in adult patients: • who have intolerance to oral iron or have had unsatisfactory response to oral iron or • who have chronic kidney disease (CKD). Ferumoxytol is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in adult patients: • who have intolerance to oral iron or have had unsatisfactory response to oral iron ( 1 ) or • who have chronic kidney disease (CKD). ( 1 )
Excerpt only. Read the full label for complete information.