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 POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

vigabatrin 500 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-366
Product ID 59651-366_7fa314e2-0506-4061-9058-435a3b5df40d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213899
Listing Expiration 2026-12-31
Marketing Start 2021-09-29

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651366
Hyphenated Format 59651-366

Supplemental Identifiers

RxCUI
250820
UPC
0359651366073
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 ANDA213899 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 50 PACKET in 1 CARTON (59651-366-50) / 1 POWDER, FOR SOLUTION in 1 PACKET (59651-366-07)
source: ndc

Packages (1)

59651-366-50 50 PACKET in 1 CARTON (59651-366-50) / 1 POWDER, FOR SOLUTION in 1 PACKET (59651-366-07)

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": "7fa314e2-0506-4061-9058-435a3b5df40d", "openfda": {"nui": ["N0000175753"], "upc": ["0359651366073"], "unii": ["GR120KRT6K"], "rxcui": ["250820"], "spl_set_id": ["c97ce40c-1c5a-479d-9188-5ce03cf7e065"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 PACKET in 1 CARTON (59651-366-50)  / 1 POWDER, FOR SOLUTION in 1 PACKET (59651-366-07)", "package_ndc": "59651-366-50", "marketing_start_date": "20210929"}], "brand_name": "Vigabatrin", "product_id": "59651-366_7fa314e2-0506-4061-9058-435a3b5df40d", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Anti-epileptic Agent [EPC]"], "product_ndc": "59651-366", "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": "ANDA213899", "marketing_category": "ANDA", "marketing_start_date": "20210929", "listing_expiration_date": "20261231"}