glatiramer acetate

Generic: glatiramer acetate

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glatiramer acetate
Generic Name glatiramer acetate
Labeler zydus pharmaceuticals usa inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

glatiramer acetate 40 mg/mL

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1549
Product ID 70710-1549_f7c61e5d-41a8-4a49-bc8e-4a00713f2a3e
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 707101549
Hyphenated Format 70710-1549

Supplemental Identifiers

RxCUI
1111641 1487361
UPC
0370710154967 0370710154899
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
  • 40 mg/mL
source: ndc
Packaging
  • 12 BLISTER PACK in 1 CARTON (70710-1549-6) / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE (70710-1549-2)
source: ndc

Packages (1)

70710-1549-6 12 BLISTER PACK in 1 CARTON (70710-1549-6) / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE (70710-1549-2)

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": "f7c61e5d-41a8-4a49-bc8e-4a00713f2a3e", "openfda": {"upc": ["0370710154967", "0370710154899"], "unii": ["5M691HL4BO"], "rxcui": ["1111641", "1487361"], "spl_set_id": ["0aa4ff2a-ce8e-46cd-830f-a264cc582be2"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (70710-1549-6)  / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE (70710-1549-2)", "package_ndc": "70710-1549-6", "marketing_start_date": "20251110"}], "brand_name": "GLATIRAMER ACETATE", "product_id": "70710-1549_f7c61e5d-41a8-4a49-bc8e-4a00713f2a3e", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "70710-1549", "generic_name": "glatiramer acetate", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GLATIRAMER ACETATE", "active_ingredients": [{"name": "GLATIRAMER ACETATE", "strength": "40 mg/mL"}], "application_number": "ANDA208468", "marketing_category": "ANDA", "marketing_start_date": "20251110", "listing_expiration_date": "20261231"}