What is NDC 67457-797?

67457-797 is the product NDC for Ferric Carboxymaltose, Ferric carboxymaltose 50 mg/mL injection, solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Mylan Institutional LLC, NDC labeler code 67457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Ferric Carboxymaltose?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Ferric Carboxymaltose NDC 67457-797 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)67457-797Labeler and product segments. Claims need a package NDC.

Product NDC at billing width67457-0797Add 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
67457-797-15	67457079715	1 VIAL, SINGLE-DOSE in 1 CARTON (67457-797-15) / 15 mL in 1 VIAL, SINGLE-DOSE (67457-797-00)Marketed from Jul 1, 2026

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): Ferric Carboxymaltose
Generic name (nonproprietary): ferric carboxymaltose
Active ingredients: Ferric carboxymaltose — 50 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: Mylan Institutional LLCNDC labeler code 67457
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212572
Marketing start: Jul 1, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Iron (Chemical structure)Phosphate Chelating Activity (Mechanism)
Identifiers: Product ID 67457-797_492684f4-56c7-4319-a821-7db252a6caa7SPL ID 492684f4-56c7-4319-a821-7db252a6caa7SPL set ID d6a5cd2d-86bd-4042-974f-46e14d65fc2dRxCUI 1435169UNII 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

N467457079715 followed by a unit qualifier and the quantity

Package 67457-0797-15. 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 Aug 15, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Ferric carboxymaltose injection is indicated for the treatment of: • iron deficiency anemia (IDA) in: o adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. o 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. Ferric carboxymaltose injection is an iron replacement product indicated for the treatment of: • iron deficiency anemia (IDA) in: o adult and pediatric patients 1 year of age and older who have either intolerance or an unsatisfactory response to oral iron. ( 1 ) o adul…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67457-797

What is NDC 67457-797?: 67457-797 is the product NDC for Ferric Carboxymaltose, Ferric carboxymaltose 50 mg/mL injection, solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Ferric Carboxymaltose.
What is the active ingredient?: Ferric carboxymaltose.
Who is the labeler?: Mylan Institutional LLC, NDC labeler code 67457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ferric Carboxymaltose?: 3 other product NDCs are listed under this name. See all Ferric Carboxymaltose NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Ferric Carboxymaltose NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Ferric Carboxymaltose	Ferric carboxymaltose 50 mg/mL	Injection, SolutionIntravenous	Mylan Institutional LLC	72078-048	72078-0048-20
Ferric Carboxymaltoseferric carboxymaltose injection	Ferric carboxymaltose 50 mg/mL	Injection, SolutionIntravenous	Sandoz, Inc.	0781-3542	00781-3542-94
Ferric Carboxymaltose	Ferric carboxymaltose 50 mg/mL	Injection, SolutionIntravenous	Mylan Institutional LLC	72078-060	72078-0060-99