copaxone

Generic: glatiramer acetate

Labeler: teva neuroscience, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name copaxone
Generic Name glatiramer acetate
Labeler teva neuroscience, inc.
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

glatiramer acetate 40 mg/mL

Manufacturer
Teva Neuroscience, Inc.

Identifiers & Regulatory

Product NDC 68546-325
Product ID 68546-325_5a691b1f-367f-4635-a7d6-0111361a2dbb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020622
Listing Expiration 2026-12-31
Marketing Start 2014-01-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68546325
Hyphenated Format 68546-325

Supplemental Identifiers

RxCUI
1111641 1111642 1487361 1487363
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 copaxone (source: ndc)
Generic Name glatiramer acetate (source: ndc)
Application Number NDA020622 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 6 BLISTER PACK in 1 CARTON (68546-325-06) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS
  • 12 BLISTER PACK in 1 CARTON (68546-325-12) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS
source: ndc

Packages (2)

68546-325-06 6 BLISTER PACK in 1 CARTON (68546-325-06) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS 68546-325-12 12 BLISTER PACK in 1 CARTON (68546-325-12) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS

Ingredients (1)

glatiramer acetate (40 mg/mL)

Linked Drug Pages (1)

Copaxone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "5a691b1f-367f-4635-a7d6-0111361a2dbb", "openfda": {"unii": ["5M691HL4BO"], "rxcui": ["1111641", "1111642", "1487361", "1487363"], "spl_set_id": ["aa88f583-4f5f-433b-80b4-1f4c9fb28357"], "manufacturer_name": ["Teva Neuroscience, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BLISTER PACK in 1 CARTON (68546-325-06)  / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "68546-325-06", "marketing_start_date": "20140129"}, {"sample": false, "description": "12 BLISTER PACK in 1 CARTON (68546-325-12)  / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "68546-325-12", "marketing_start_date": "20140129"}], "brand_name": "Copaxone", "product_id": "68546-325_5a691b1f-367f-4635-a7d6-0111361a2dbb", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "68546-325", "generic_name": "Glatiramer Acetate", "labeler_name": "Teva Neuroscience, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Copaxone", "active_ingredients": [{"name": "GLATIRAMER ACETATE", "strength": "40 mg/mL"}], "application_number": "NDA020622", "marketing_category": "NDA", "marketing_start_date": "20140129", "listing_expiration_date": "20261231"}