🇺🇸
United States · US · US:59651-367_42eb5d5d-049e-4291-bab0-12d3369cba8c
Vigabatrin
In shortageOrange BookUNIISPLATC N03AG04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC codeN03AG04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1159651367011 BOTTLE in 1 CARTON (59651-367-01) / 100 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
GR120KRT6K
VIGABATRIN
RxCUI 14851
Orange Book
A215601
AB
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Vigabatrin Oral Solution
Raw payload (JSON)
{
"unii": {
"unii": "GR120KRT6K",
"rxcui": "14851",
"inchikey": "PJDFLNIOAUIZSL-UHFFFAOYSA-N",
"display_name": "VIGABATRIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e7cbc0a5-8c28-4451-9176-b608e228ba66": {
"match": "brand_token",
"title": "VIGABATRIN POWDER, FOR SOLUTION [PAR HEALTH USA, LLC]",
"spl_version": "29",
"published_date": "2026-04-23"
}
},
"productid": "59651-367_42eb5d5d-049e-4291-bab0-12d3369cba8c",
"productndc": "59651-367",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "215601",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "May 10, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VIGABATRIN",
"shortage_reason": "Vigabatrin Oral Solution",
"shortage_status": "current",
"proprietary_name": "Vigabatrin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA215601",
"marketing_category": "ANDA",
"nonproprietary_name": "Vigabatrin",
"start_marketing_date": "20220510",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code N03AG04.
Access this data programmatically
Query Vigabatrin and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.