Prescription drug · NDA
Feraheme (Ferumoxytol) NDC 59338-775
Ferumoxytol non-stoichiometric magnetite 510 mg/17mL · Injection · Intravenous · AMAG Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59338-775-01 | 59338077501 | 1 VIAL, SINGLE-USE in 1 CARTON (59338-775-01) / 17 mL in 1 VIAL, SINGLE-USEMarketed from Jul 13, 2009 | |
| 59338-775-10 | 59338077510 | 10 VIAL, SINGLE-USE in 1 CARTON (59338-775-10) / 17 mL in 1 VIAL, SINGLE-USEMarketed from Jul 13, 2009 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Feraheme
- Generic name (nonproprietary)
- ferumoxytol
- Active ingredients
- Ferumoxytol non-stoichiometric magnetite — 510 mg/17mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- AMAG Pharmaceuticals, IncNDC labeler code 59338
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022180
- Marketing start
- Listing expires
- Other FDA classes
- Iron (Chemical structure)
- Identifiers
- Product ID 59338-775_a13ebd7b-ac6b-47c7-8c39-ba4702b66f5aSPL ID a13ebd7b-ac6b-47c7-8c39-ba4702b66f5aSPL set ID 32b0e320-a739-11dc-a704-0002a5d5c51bRxCUI 860605, 1191357UNII 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
N459338077501followed by a unit qualifier and the quantityPackage 59338-0775-01. 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)
Feraheme 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). Feraheme 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.
About NDC 59338-775
- What is NDC 59338-775?
- 59338-775 is the product NDC for Feraheme (ferumoxytol), Ferumoxytol non-stoichiometric magnetite 510 mg/17mL injection, listed with the FDA by AMAG Pharmaceuticals, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Feraheme (Ferumoxytol).
- What is the active ingredient?
- Ferumoxytol non-stoichiometric magnetite.
- Who is the labeler?
- AMAG Pharmaceuticals, Inc, NDC labeler code 59338. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Feraheme?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.