Cellular therapy · BLA
Aucatzyl (Obecabtagene autoleucel) NDC 83047-410
Kit · Autolus Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83047-410-04 | 83047041004 | 1 KIT in 1 PACKAGE (83047-410-04) * 1 SUSPENSION in 1 BAG (83047-100-30) * 1 SUSPENSION in 1 BAG (83047-100-10) * 1 SUSPENSION in 1 BAG (83047-300-30) * 1 SUSPENSION in 1 BAG (83047-010-10)Marketed from Nov 8, 2024 |
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)
- Aucatzyl
- Generic name (nonproprietary)
- obecabtagene autoleucel
- Dosage form
- Kit
- Labeler
- Autolus Inc.NDC labeler code 83047
- Product type
- Cellular therapy
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125813
- Marketing start
- Listing expires
- Identifiers
- Product ID 83047-410_5ff8c7fb-5a15-4817-bd53-ae3ea48d8449SPL ID 5ff8c7fb-5a15-4817-bd53-ae3ea48d8449SPL set ID 4fef6986-b988-45e4-8c20-b14f0ef1f538RxCUI 2700168, 2700173, 2700174, 2700175
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
N483047041004followed by a unit qualifier and the quantityPackage 83047-0410-04. 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)
1 INDICATION AND USAGE AUCATZYL is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). AUCATZYL is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 83047-410
- What is NDC 83047-410?
- 83047-410 is the product NDC for Aucatzyl (obecabtagene autoleucel) kit, listed with the FDA by Autolus Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Aucatzyl (Obecabtagene autoleucel).
- Who is the labeler?
- Autolus Inc., NDC labeler code 83047. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Aucatzyl?
- 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.