vigabatrin

Generic: vigabatrin

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vigabatrin
Generic Name vigabatrin
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

vigabatrin 500 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-367
Product ID 59651-367_42eb5d5d-049e-4291-bab0-12d3369cba8c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215601
Listing Expiration 2026-12-31
Marketing Start 2022-05-10

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651367
Hyphenated Format 59651-367

Supplemental Identifiers

RxCUI
199521
UPC
0359651367018
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 ANDA215601 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (59651-367-01) / 100 TABLET in 1 BOTTLE
source: ndc

Packages (1)

59651-367-01 1 BOTTLE in 1 CARTON (59651-367-01) / 100 TABLET in 1 BOTTLE

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": "42eb5d5d-049e-4291-bab0-12d3369cba8c", "openfda": {"nui": ["N0000175753"], "upc": ["0359651367018"], "unii": ["GR120KRT6K"], "rxcui": ["199521"], "spl_set_id": ["4aaea88b-e0fd-45e3-bb02-604bf8ee9b5b"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (59651-367-01)  / 100 TABLET in 1 BOTTLE", "package_ndc": "59651-367-01", "marketing_start_date": "20220510"}], "brand_name": "Vigabatrin", "product_id": "59651-367_42eb5d5d-049e-4291-bab0-12d3369cba8c", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]"], "product_ndc": "59651-367", "generic_name": "Vigabatrin", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vigabatrin", "active_ingredients": [{"name": "VIGABATRIN", "strength": "500 mg/1"}], "application_number": "ANDA215601", "marketing_category": "ANDA", "marketing_start_date": "20220510", "listing_expiration_date": "20261231"}