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United States · US · US:0245-6001_2734e899-4ddc-836c-e063-6294a90a128f
VIGADRONE
In shortageOrange BookUNIISPLATC N03AG04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUpsher-Smith Laboratories, LLC
CountryUS (United States)
ATC codeN03AG04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1102456001111 BOTTLE in 1 CARTON (0245-6001-11) / 100 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
GR120KRT6K
VIGABATRIN
RxCUI 14851
Orange Book
A214749
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": {
"5e5e7554-d0f4-47f7-a434-cc5ca5a9826f": {
"match": "brand_token",
"title": "VIGADRONE (VIGABATRIN) POWDER, FOR SOLUTION [UPSHER-SMITH LABORATORIES, LLC]",
"spl_version": "8",
"published_date": "2025-07-28"
}
},
"productid": "0245-6001_2734e899-4ddc-836c-e063-6294a90a128f",
"productndc": "0245-6001",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "214749",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Jun 29, 2023"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VIGABATRIN",
"shortage_reason": "Vigabatrin Oral Solution",
"shortage_status": "current",
"proprietary_name": "VIGADRONE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA214749",
"marketing_category": "ANDA",
"nonproprietary_name": "Vigabatrin",
"start_marketing_date": "20230629",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code N03AG04.
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