Injectafer (ferric carboxymaltose) NDC 0517-0620

NDC codes

FDA NDC Directory

Product NDC (as listed)0517-0620Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00517-0620Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0517-0620-01	00517062001	1 VIAL, SINGLE-DOSE in 1 BOX (0517-0620-01) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Jun 1, 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): Injectafer
Generic name (nonproprietary): ferric carboxymaltose
Active ingredients: Ferric carboxymaltose — 50 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: American Regent, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 203565
Marketing start: Jun 1, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Iron (Chemical structure)Phosphate Chelating Activity (Mechanism)
Identifiers: Product ID 0517-0620_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.

How CPT relates to drug billing

NDC on a medical claim

N400517062001 followed by a unit qualifier and the quantity

Package 00517-0620-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under NDA 203565

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 203565
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 injection	Ferric carboxymaltose 50 mg/mL	Injection, SolutionIntravenous	American Regent, Inc.	0517-0650