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United States · US · US:0245-0556_3aae9c74-44ec-cc53-e063-6294a90a5538
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
- ndc11024505565050 PACKET in 1 CARTON (0245-0556-50) / 10 mL in 1 PACKET (0245-0556-89)
Annotations
UNII (FDA Substance ID)
GR120KRT6K
VIGABATRIN
RxCUI 14851
Orange Book
A210196
AA
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": "0245-0556_3aae9c74-44ec-cc53-e063-6294a90a5538",
"productndc": "0245-0556",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "210196",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "500MG/PACKET",
"product_no": "001",
"approval_date": "Jun 21, 2018"
}
],
"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/mL",
"application_number": "ANDA210196",
"marketing_category": "ANDA",
"nonproprietary_name": "vigabatrin",
"start_marketing_date": "20180621",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N03AG04.
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