tecelra

Generic: afamitresgene autoleucel

Labeler: uswm, llc
NDC Directory CELLULAR THERAPY BLA Inactive Finished

Drug Facts

Product Profile

Brand Name tecelra
Generic Name afamitresgene autoleucel
Labeler uswm, llc
Dosage Form INJECTION, SUSPENSION
Routes
INTRAVENOUS
Active Ingredients

afamitresgene autoleucel 10000000000 1/1

Manufacturer
USWM, LLC

Identifiers & Regulatory

Product NDC 83205-0001
Product ID 83205-0001_28fa3284-38e4-4fdf-8991-2b52fe3f19fc
Product Type CELLULAR THERAPY
Marketing Category BLA
Application Number BLA125789
Listing Expiration 2027-12-31
Marketing Start 2024-08-02

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 832050001
Hyphenated Format 83205-0001

Supplemental Identifiers

RxCUI
2690269 2690275
UNII
CUY18BJ7BP

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tecelra (source: ndc)
Generic Name afamitresgene autoleucel (source: ndc)
Application Number BLA125789 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10000000000 1/1
source: ndc
Packaging
  • 1 INJECTION, SUSPENSION in 1 BAG (83205-0001-2)
source: ndc

Packages (1)

83205-0001-2 1 INJECTION, SUSPENSION in 1 BAG (83205-0001-2)

Ingredients (1)

afamitresgene autoleucel (10000000000 1/1)

Linked Drug Pages (1)

TECELRA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "28fa3284-38e4-4fdf-8991-2b52fe3f19fc", "openfda": {"unii": ["CUY18BJ7BP"], "rxcui": ["2690269", "2690275"], "spl_set_id": ["ab24631f-3364-46e1-8074-7244863bcbab"], "manufacturer_name": ["USWM, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 INJECTION, SUSPENSION in 1 BAG (83205-0001-2)", "package_ndc": "83205-0001-2", "marketing_start_date": "20240802"}], "brand_name": "TECELRA", "product_id": "83205-0001_28fa3284-38e4-4fdf-8991-2b52fe3f19fc", "dosage_form": "INJECTION, SUSPENSION", "product_ndc": "83205-0001", "generic_name": "afamitresgene autoleucel", "labeler_name": "USWM, LLC", "product_type": "CELLULAR THERAPY", "brand_name_base": "TECELRA", "active_ingredients": [{"name": "AFAMITRESGENE AUTOLEUCEL", "strength": "10000000000 1/1"}], "application_number": "BLA125789", "marketing_category": "BLA", "marketing_start_date": "20240802", "listing_expiration_date": "20271231"}