vigabatrin

Generic: vigabatrin

Labeler: hikma pharmaceuticals usa inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vigabatrin
Generic Name vigabatrin
Labeler hikma pharmaceuticals usa inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

vigabatrin 500 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc

Identifiers & Regulatory

Product NDC 0054-0652
Product ID 0054-0652_f575e137-5300-4e13-a40e-5573f6c8a066
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213104
Listing Expiration 2026-12-31
Marketing Start 2022-09-09

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00540652
Hyphenated Format 0054-0652

Supplemental Identifiers

RxCUI
199521
UPC
0300540652258
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 ANDA213104 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0054-0652-25)
source: ndc

Packages (1)

0054-0652-25 100 TABLET in 1 BOTTLE (0054-0652-25)

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": "f575e137-5300-4e13-a40e-5573f6c8a066", "openfda": {"nui": ["N0000175753"], "upc": ["0300540652258"], "unii": ["GR120KRT6K"], "rxcui": ["199521"], "spl_set_id": ["5ed8d293-b7d8-4c66-9c31-8075e6f99092"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0054-0652-25)", "package_ndc": "0054-0652-25", "marketing_start_date": "20220909"}], "brand_name": "Vigabatrin", "product_id": "0054-0652_f575e137-5300-4e13-a40e-5573f6c8a066", "dosage_form": "TABLET", "pharm_class": ["Anti-epileptic Agent [EPC]"], "product_ndc": "0054-0652", "generic_name": "Vigabatrin", "labeler_name": "Hikma Pharmaceuticals USA Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vigabatrin", "active_ingredients": [{"name": "VIGABATRIN", "strength": "500 mg/1"}], "application_number": "ANDA213104", "marketing_category": "ANDA", "marketing_start_date": "20220909", "listing_expiration_date": "20261231"}