Cellular therapy · BLA
Omisirge (Omidubicel-onlv) NDC 73441-800
Kit · Gamida Cell Inc.
NDC codes
FDA NDC Directory| 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.NDC labeler code 73441
- Product type
- Cellular therapy
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125738
- Marketing start
- Listing expires
- 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
N473441080004followed by a unit qualifier and the quantityPackage 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 . 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.
About NDC 73441-800
- What is NDC 73441-800?
- 73441-800 is the product NDC for Omisirge (omidubicel-onlv) kit, listed with the FDA by Gamida Cell Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Omisirge (Omidubicel-onlv).
- Who is the labeler?
- Gamida Cell Inc., NDC labeler code 73441. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Omisirge?
- 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.