glatiramer acetate

Generic: glatiramer acetate

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glatiramer acetate
Generic Name glatiramer acetate
Labeler sun pharmaceutical industries, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

glatiramer acetate 40 mg/mL

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 47335-991
Product ID 47335-991_9153cc14-8516-4cdc-a47e-3b8368f573e5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206873
Listing Expiration 2026-12-31
Marketing Start 2025-08-15

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 47335991
Hyphenated Format 47335-991

Supplemental Identifiers

RxCUI
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 ANDA206873 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 12 BLISTER PACK in 1 CARTON (47335-991-02) / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE
source: ndc

Packages (1)

47335-991-02 12 BLISTER PACK in 1 CARTON (47335-991-02) / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE

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": "9153cc14-8516-4cdc-a47e-3b8368f573e5", "openfda": {"unii": ["5M691HL4BO"], "rxcui": ["1487361"], "spl_set_id": ["dfacc3e2-5c91-41de-a377-873276a5cf67"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (47335-991-02)  / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE", "package_ndc": "47335-991-02", "marketing_start_date": "20250815"}], "brand_name": "Glatiramer Acetate", "product_id": "47335-991_9153cc14-8516-4cdc-a47e-3b8368f573e5", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "47335-991", "generic_name": "Glatiramer Acetate", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glatiramer Acetate", "active_ingredients": [{"name": "GLATIRAMER ACETATE", "strength": "40 mg/mL"}], "application_number": "ANDA206873", "marketing_category": "ANDA", "marketing_start_date": "20250815", "listing_expiration_date": "20261231"}