glatopa

Generic: glatiramer acetate

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name glatopa
Generic Name glatiramer acetate
Labeler sandoz inc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

glatiramer acetate 40 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 0781-3250
Product ID 0781-3250_ccec47d1-47be-4953-a7fe-ad66c9186962
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 07813250
Hyphenated Format 0781-3250

Supplemental Identifiers

RxCUI
1111641 1487361 1654630 2000007
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 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 (0781-3250-89) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS (0781-3250-71)
source: ndc

Packages (1)

0781-3250-89 12 BLISTER PACK in 1 CARTON (0781-3250-89) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS (0781-3250-71)

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": "ccec47d1-47be-4953-a7fe-ad66c9186962", "openfda": {"unii": ["5M691HL4BO"], "rxcui": ["1111641", "1487361", "1654630", "2000007"], "spl_set_id": ["5f01e40a-b6f6-40fb-b37c-3d06f1428e86"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 BLISTER PACK in 1 CARTON (0781-3250-89)  / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS (0781-3250-71)", "package_ndc": "0781-3250-89", "marketing_start_date": "20180212"}], "brand_name": "Glatopa", "product_id": "0781-3250_ccec47d1-47be-4953-a7fe-ad66c9186962", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "0781-3250", "generic_name": "Glatiramer Acetate", "labeler_name": "Sandoz Inc", "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"}