Prescription drug · NDA
Injectafer (Ferric carboxymaltose injection) NDC 0517-0650
Ferric carboxymaltose 50 mg/mL · Injection, Solution · Intravenous · American Regent, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0517-0650-01 | 00517065001 | 1 VIAL, SINGLE-DOSE in 1 BOX (0517-0650-01) / 15 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 12, 2013 |
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)
- Injectafer
- Generic name (nonproprietary)
- ferric carboxymaltose injection
- Active ingredients
- Ferric carboxymaltose — 50 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- American Regent, Inc.NDC labeler code 0517
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 203565
- Marketing start
- Listing expires
- Other FDA classes
- Iron (Chemical structure)Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 0517-0650_67e24a72-0a7b-4fc9-876e-fd2f71f802c0SPL ID 67e24a72-0a7b-4fc9-876e-fd2f71f802c0SPL set ID 517b4a19-45b3-4286-9f6a-ced4e10447deRxCUI 1435169, 1435174, 2552400, 2552401, 2602296, 2602297UNII 6897GXD6OE
- Pharmacologic class
- Parenteral Iron Replacement; Phosphate Binder
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
N400517065001followed by a unit qualifier and the quantityPackage 00517-0650-01. 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)
Injectafer is indicated for the treatment of: • iron deficiency anemia (IDA) in: adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. adult patients who have non-dialysis dependent chronic kidney disease. • iron deficiency in adult patients with heart failure and New York Heart Association class II/III to improve exercise capacity. Injectafer is an iron replacement product indicated for the treatment of: • iron deficiency anemia (IDA) in: adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. ( 1 ) adult patients who have non-dialysis dependent chronic…
Excerpt only. Read the full label for complete information.
About NDC 0517-0650
- What is NDC 0517-0650?
- 0517-0650 is the product NDC for Injectafer (ferric carboxymaltose injection), Ferric carboxymaltose 50 mg/mL injection, solution, listed with the FDA by American Regent, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Injectafer (Ferric Carboxymaltose Injection).
- What is the active ingredient?
- Ferric carboxymaltose.
- Who is the labeler?
- American Regent, Inc., NDC labeler code 0517. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Injectafer?
- 2 other product NDCs are listed under this name. See all Injectafer NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Injectafer products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Injectaferferric carboxymaltose injection | Ferric carboxymaltose 50 mg/mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-0602 | 00517-0602-01 |
| Injectaferferric carboxymaltose | Ferric carboxymaltose 50 mg/mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-0620 | 00517-0620-01 |
Other NDCs under NDA 203565
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ferric Carboxymaltoseferric carboxymaltose injection | Ferric carboxymaltose 50 mg/mL | Injection, SolutionIntravenous | Sandoz, Inc. | 0781-3542 |
| Injectaferferric carboxymaltose injection | Ferric carboxymaltose 50 mg/mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-0602 |
| Injectaferferric carboxymaltose | Ferric carboxymaltose 50 mg/mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-0620 |