glatiramer acetate

Generic: glatiramer

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

Drug Facts

Product Profile

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

glatiramer acetate 40 mg/mL

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-6961
Product ID 0378-6961_f5070abd-2219-47fa-8ff2-c0b147ea3eb7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206936
Listing Expiration 2026-12-31
Marketing Start 2017-10-04

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03786961
Hyphenated Format 0378-6961

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 (source: ndc)
Application Number ANDA206936 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 12 BLISTER PACK in 1 CARTON (0378-6961-12) / 1 SYRINGE in 1 BLISTER PACK (0378-6961-32) / 1 mL in 1 SYRINGE
source: ndc

Packages (1)

0378-6961-12 12 BLISTER PACK in 1 CARTON (0378-6961-12) / 1 SYRINGE in 1 BLISTER PACK (0378-6961-32) / 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": "f5070abd-2219-47fa-8ff2-c0b147ea3eb7", "openfda": {"unii": ["5M691HL4BO"], "rxcui": ["1487361"], "spl_set_id": ["456a34c7-8511-4000-99a7-ad8f8de6d35e"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (0378-6961-12)  / 1 SYRINGE in 1 BLISTER PACK (0378-6961-32)  / 1 mL in 1 SYRINGE", "package_ndc": "0378-6961-12", "marketing_start_date": "20171004"}], "brand_name": "Glatiramer Acetate", "product_id": "0378-6961_f5070abd-2219-47fa-8ff2-c0b147ea3eb7", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "0378-6961", "generic_name": "Glatiramer", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glatiramer Acetate", "active_ingredients": [{"name": "GLATIRAMER ACETATE", "strength": "40 mg/mL"}], "application_number": "ANDA206936", "marketing_category": "ANDA", "marketing_start_date": "20171004", "listing_expiration_date": "20261231"}