vigabatrin

Generic: vigabatrin

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vigabatrin
Generic Name vigabatrin
Labeler actavis pharma, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

vigabatrin 500 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-3851
Product ID 0591-3851_c29a7450-ee68-466a-a33f-bf5065da1593
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209822
Listing Expiration 2026-12-31
Marketing Start 2019-02-06

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 05913851
Hyphenated Format 0591-3851

Supplemental Identifiers

RxCUI
199521
UNII
GR120KRT6K
NUI
N0000175753

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 vigabatrin (source: ndc)
Generic Name vigabatrin (source: ndc)
Application Number ANDA209822 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (0591-3851-01)
source: ndc

Packages (1)

0591-3851-01 100 TABLET, FILM COATED in 1 BOTTLE (0591-3851-01)

Ingredients (1)

vigabatrin (500 mg/1)

Linked Drug Pages (1)

Vigabatrin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c29a7450-ee68-466a-a33f-bf5065da1593", "openfda": {"nui": ["N0000175753"], "unii": ["GR120KRT6K"], "rxcui": ["199521"], "spl_set_id": ["8dc7bd15-2636-4d58-b651-dd117ca43dbd"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (0591-3851-01)", "package_ndc": "0591-3851-01", "marketing_start_date": "20190206"}], "brand_name": "Vigabatrin", "product_id": "0591-3851_c29a7450-ee68-466a-a33f-bf5065da1593", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]"], "product_ndc": "0591-3851", "generic_name": "Vigabatrin", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vigabatrin", "active_ingredients": [{"name": "VIGABATRIN", "strength": "500 mg/1"}], "application_number": "ANDA209822", "marketing_category": "ANDA", "marketing_start_date": "20190206", "listing_expiration_date": "20261231"}