glatiramer acetate

Generic: glatiramer acetate

Labeler: italfarmaco spa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glatiramer acetate
Generic Name glatiramer acetate
Labeler italfarmaco spa
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

glatiramer acetate 20 mg/mL

Manufacturer
Italfarmaco SpA

Identifiers & Regulatory

Product NDC 11797-764
Product ID 11797-764_1bf557de-bcff-476b-b7c3-c7f7b8ddbfb2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208468
Listing Expiration 2026-12-31
Marketing Start 2025-11-10

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 11797764
Hyphenated Format 11797-764

Supplemental Identifiers

RxCUI
1111641 1487361
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 (source: ndc)
Application Number ANDA208468 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 30 SYRINGE in 1 CARTON (11797-764-03) / 1 mL in 1 SYRINGE
source: ndc

Packages (1)

11797-764-03 30 SYRINGE in 1 CARTON (11797-764-03) / 1 mL in 1 SYRINGE

Ingredients (1)

glatiramer acetate (20 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": "1bf557de-bcff-476b-b7c3-c7f7b8ddbfb2", "openfda": {"unii": ["5M691HL4BO"], "rxcui": ["1111641", "1487361"], "spl_set_id": ["1b3a60de-2191-4b15-be69-01329da87711"], "manufacturer_name": ["Italfarmaco SpA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 SYRINGE in 1 CARTON (11797-764-03)  / 1 mL in 1 SYRINGE", "package_ndc": "11797-764-03", "marketing_start_date": "20251110"}], "brand_name": "GLATIRAMER ACETATE", "product_id": "11797-764_1bf557de-bcff-476b-b7c3-c7f7b8ddbfb2", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "11797-764", "generic_name": "glatiramer acetate", "labeler_name": "Italfarmaco SpA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GLATIRAMER ACETATE", "active_ingredients": [{"name": "GLATIRAMER ACETATE", "strength": "20 mg/mL"}], "application_number": "ANDA208468", "marketing_category": "ANDA", "marketing_start_date": "20251110", "listing_expiration_date": "20261231"}