glatiramer acetate

Generic: glatiramer acetate injection

Labeler: upsher-smith laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glatiramer acetate
Generic Name glatiramer acetate injection
Labeler upsher-smith laboratories, llc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

glatiramer acetate 40 mg/mL

Manufacturer
UPSHER-SMITH LABORATORIES, LLC

Identifiers & Regulatory

Product NDC 0832-6085
Product ID 0832-6085_991aa361-3f99-42cd-948b-5b1271b346c5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214741
Listing Expiration 2027-12-31
Marketing Start 2026-01-23

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 08326085
Hyphenated Format 0832-6085

Supplemental Identifiers

RxCUI
1111641 1487361
UPC
0308326084309 0308326085122
UNII
5M691HL4BO

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 glatiramer acetate (source: ndc)
Generic Name glatiramer acetate injection (source: ndc)
Application Number ANDA214741 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 12 SYRINGE, GLASS in 1 CARTON (0832-6085-12) / 1 mL in 1 SYRINGE, GLASS (0832-6085-89)
source: ndc

Packages (1)

0832-6085-12 12 SYRINGE, GLASS in 1 CARTON (0832-6085-12) / 1 mL in 1 SYRINGE, GLASS (0832-6085-89)

Ingredients (1)

glatiramer acetate (40 mg/mL)

Linked Drug Pages (1)

Glatiramer Acetate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "991aa361-3f99-42cd-948b-5b1271b346c5", "openfda": {"upc": ["0308326084309", "0308326085122"], "unii": ["5M691HL4BO"], "rxcui": ["1111641", "1487361"], "spl_set_id": ["707a64ef-964e-44a3-8a0f-fcc2eb5b1af2"], "manufacturer_name": ["UPSHER-SMITH LABORATORIES, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 SYRINGE, GLASS in 1 CARTON (0832-6085-12)  / 1 mL in 1 SYRINGE, GLASS (0832-6085-89)", "package_ndc": "0832-6085-12", "marketing_start_date": "20260123"}], "brand_name": "Glatiramer Acetate", "product_id": "0832-6085_991aa361-3f99-42cd-948b-5b1271b346c5", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "0832-6085", "generic_name": "Glatiramer Acetate Injection", "labeler_name": "UPSHER-SMITH LABORATORIES, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glatiramer Acetate", "active_ingredients": [{"name": "GLATIRAMER ACETATE", "strength": "40 mg/mL"}], "application_number": "ANDA214741", "marketing_category": "ANDA", "marketing_start_date": "20260123", "listing_expiration_date": "20271231"}