Omisirge (omidubicel-onlv) NDC 73441-800

NDC codes

FDA NDC Directory

Product NDC (as listed)73441-800Labeler and product segments. Claims need a package NDC.

Product NDC at billing width73441-0800Add 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
73441-800-04	73441080004	1 KIT in 1 KIT (73441-800-04) * 10 mL in 1 BAG (73441-200-01) * 40 mL in 1 BAG (73441-400-01) * 20 mL in 1 BAG (73441-100-01) * 80 mL in 1 BAG (73441-300-01)Marketed from May 1, 2023

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): Omisirge
Generic name (nonproprietary): omidubicel-onlv
Dosage form: Kit
Labeler: Gamida Cell Inc.
Product type: Cellular therapy
Marketing category: BLA — Biologics License ApplicationApplication BLA 125738
Marketing start: May 1, 2023
Listing expires: Dec 31, 2027
Identifiers: Product ID 73441-800_d383cdf1-017c-46c2-9130-d6e5c2a7dcf7SPL ID d383cdf1-017c-46c2-9130-d6e5c2a7dcf7SPL set ID 979803c9-956c-42e7-9d75-c37cc4e90632RxCUI 2637360, 2637362, 2637363, 2637364

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.

NDC on a medical claim

N473441080004 followed by a unit qualifier and the quantity

Package 73441-0800-04. 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 Feb 19, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

OMISIRGE is a nicotinamide modified allogeneic hematopoietic progenitor cell therapy derived from cord blood indicated for the treatment of: adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infections. ( 1.1 ) adults and pediatric patients 6 years and older with severe aplastic anemia (SAA) following reduced intensity conditioning. ( 1.2 ) 1.1 Hematologic Malignancies OMISIRGE is indicated for the treatment of adults and pediatric patients 12 years and older with hematologic malignancies who are planned for …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)