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United States · US · US:0591-3851_c29a7450-ee68-466a-a33f-bf5065da1593
Vigabatrin
In shortageOrange BookUNIISPLATC N03AG04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerActavis Pharma, Inc.
CountryUS (United States)
ATC codeN03AG04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110591385101100 TABLET, FILM COATED in 1 BOTTLE (0591-3851-01)
Annotations
UNII (FDA Substance ID)
GR120KRT6K
VIGABATRIN
RxCUI 14851
Orange Book
A209822
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": "0591-3851_c29a7450-ee68-466a-a33f-bf5065da1593",
"productndc": "0591-3851",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "209822",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Jan 14, 2019"
}
],
"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": "ANDA209822",
"marketing_category": "ANDA",
"nonproprietary_name": "Vigabatrin",
"start_marketing_date": "20190206",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code N03AG04.
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