Cellular therapy · BLA
Breyanzi (Lisocabtagene maraleucel) NDC 73153-900
Kit · Juno Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73153-900-01 | 73153090001 | 1 KIT in 1 CARTON (73153-900-01) * 5 mL in 1 VIAL, SINGLE-DOSE (73153-902-04) * 5 mL in 1 VIAL, SINGLE-DOSE (73153-901-08)Marketed from Feb 5, 2021 |
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)
- Breyanzi
- Generic name (nonproprietary)
- lisocabtagene maraleucel
- Dosage form
- Kit
- Labeler
- Juno Therapeutics, Inc.NDC labeler code 73153
- Product type
- Cellular therapy
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125714
- Marketing start
- Listing expires
- Identifiers
- Product ID 73153-900_6e83a5e5-a286-42e0-b22b-7d5f0b2cb920SPL ID 6e83a5e5-a286-42e0-b22b-7d5f0b2cb920SPL set ID 594bb413-af3b-4b97-afb3-bfe2b174f2edRxCUI 2479140, 2479145
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
N473153090001followed by a unit qualifier and the quantityPackage 73153-0900-01. 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)
BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of: • adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have: • refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or • refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to…
Excerpt only. Read the full label for complete information.
About NDC 73153-900
- What is NDC 73153-900?
- 73153-900 is the product NDC for Breyanzi (lisocabtagene maraleucel) kit, listed with the FDA by Juno Therapeutics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Breyanzi (Lisocabtagene maraleucel).
- Who is the labeler?
- Juno Therapeutics, Inc., NDC labeler code 73153. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Breyanzi?
- 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.