glatopa

Generic: glatiramer acetate

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glatopa
Generic Name glatiramer acetate
Labeler bryant ranch prepack
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

glatiramer acetate 40 mg/mL

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-8816
Product ID 63629-8816_d1f6c590-1315-4499-9fcd-75ff92dcc5c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206921
Listing Expiration 2026-12-31
Marketing Start 2018-02-12

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636298816
Hyphenated Format 63629-8816

Supplemental Identifiers

RxCUI
1487361 2000007
UNII
5M691HL4BO

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 glatopa (source: ndc)
Generic Name glatiramer acetate (source: ndc)
Application Number ANDA206921 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 12 BLISTER PACK in 1 CARTON (63629-8816-1) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

63629-8816-1 12 BLISTER PACK in 1 CARTON (63629-8816-1) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS

Ingredients (1)

glatiramer acetate (40 mg/mL)

Linked Drug Pages (1)

Glatopa ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "d1f6c590-1315-4499-9fcd-75ff92dcc5c4", "openfda": {"unii": ["5M691HL4BO"], "rxcui": ["1487361", "2000007"], "spl_set_id": ["028fdf0e-2340-407b-bcd8-5a99accdddbf"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (63629-8816-1)  / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "63629-8816-1", "marketing_start_date": "20210910"}], "brand_name": "Glatopa", "product_id": "63629-8816_d1f6c590-1315-4499-9fcd-75ff92dcc5c4", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "63629-8816", "generic_name": "Glatiramer Acetate", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Glatopa", "active_ingredients": [{"name": "GLATIRAMER ACETATE", "strength": "40 mg/mL"}], "application_number": "ANDA206921", "marketing_category": "ANDA", "marketing_start_date": "20180212", "listing_expiration_date": "20261231"}