Cellular therapy · BLA
Tecelra (Afamitresgene autoleucel) NDC 83205-0001
Afamitresgene autoleucel 10000000000 1/1 · Injection, Suspension · Intravenous · USWM CT, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83205-0001-2 | 83205000102 | 1 INJECTION, SUSPENSION in 1 BAG (83205-0001-2)Marketed from Aug 2, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Tecelra
- Generic name (nonproprietary)
- afamitresgene autoleucel
- Active ingredients
- Afamitresgene autoleucel — 10000000000 1/1
- Dosage form
- Injection, Suspension
- Route
- Intravenous
- Labeler
- USWM CT, LLCNDC labeler code 83205
- Product type
- Cellular therapy
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125789
- Marketing start
- Listing expires
- Identifiers
- Product ID 83205-0001_bc55f8cd-4e1e-45a5-8be2-d6633ed7a7f1SPL ID bc55f8cd-4e1e-45a5-8be2-d6633ed7a7f1SPL set ID ab24631f-3364-46e1-8074-7244863bcbabRxCUI 2690269, 2690275UNII CUY18BJ7BP
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.
- NDC on a medical claim
N483205000102followed by a unit qualifier and the quantityPackage 83205-0001-02. 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)
TECELRA is indicated for the treatment of adults and pediatric patients 12 years of age and older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices. TECELRA is a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adults and pediatric patients 12 years of age and older with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*…
Excerpt only. Read the full label for complete information.
About NDC 83205-0001
- What is NDC 83205-0001?
- 83205-0001 is the product NDC for Tecelra (afamitresgene autoleucel), Afamitresgene autoleucel 10000000000 1/1 injection, suspension, listed with the FDA by USWM CT, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tecelra (Afamitresgene autoleucel).
- What is the active ingredient?
- Afamitresgene autoleucel.
- Who is the labeler?
- USWM CT, LLC, NDC labeler code 83205. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tecelra?
- 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.