Package 83205-0001-2

Brand: tecelra

Generic: afamitresgene autoleucel
NDC Package

Package Facts

Identity

Package NDC 83205-0001-2
Digits Only 8320500012
Product NDC 83205-0001
Description

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

Marketing

Marketing Status
Marketed Since 2024-08-02
Brand tecelra
Generic afamitresgene autoleucel
Sample Package No

Linked Drug Pages (1)

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"}