vigabatrin

Generic: vigabatrin

Labeler: dr. reddys laboratories inc.,
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vigabatrin
Generic Name vigabatrin
Labeler dr. reddys laboratories inc.,
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

vigabatrin 500 mg/1

Manufacturer
Dr. Reddys Laboratories Inc.,

Identifiers & Regulatory

Product NDC 43598-651
Product ID 43598-651_f9d29bec-f73b-7dc9-5f1b-7857dc0fdb74
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211539
Listing Expiration 2026-12-31
Marketing Start 2021-02-01

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43598651
Hyphenated Format 43598-651

Supplemental Identifiers

RxCUI
199521
UPC
0343598651019
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 ANDA211539 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (43598-651-01)
source: ndc

Packages (1)

43598-651-01 100 TABLET, FILM COATED in 1 BOTTLE (43598-651-01)

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": "f9d29bec-f73b-7dc9-5f1b-7857dc0fdb74", "openfda": {"nui": ["N0000175753"], "upc": ["0343598651019"], "unii": ["GR120KRT6K"], "rxcui": ["199521"], "spl_set_id": ["0afdc84c-f8ec-330a-31c9-fac4ed256931"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Dr. Reddys Laboratories Inc.,"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (43598-651-01)", "package_ndc": "43598-651-01", "marketing_start_date": "20210201"}], "brand_name": "Vigabatrin", "product_id": "43598-651_f9d29bec-f73b-7dc9-5f1b-7857dc0fdb74", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Anti-epileptic Agent [EPC]"], "product_ndc": "43598-651", "generic_name": "Vigabatrin", "labeler_name": "Dr. Reddys Laboratories Inc.,", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vigabatrin", "active_ingredients": [{"name": "VIGABATRIN", "strength": "500 mg/1"}], "application_number": "ANDA211539", "marketing_category": "ANDA", "marketing_start_date": "20210201", "listing_expiration_date": "20261231"}