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United States · US · US:80789-003_43aeb38a-b4ee-47ed-8239-c488b074f1c9
VIGAFYDE
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
- ndc1180789003151 BOTTLE in 1 CARTON (80789-003-15) / 150 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
GR120KRT6K
VIGABATRIN
RxCUI 14851
Orange Book
N217684
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": {
"8d3d6316-33ab-41e8-9485-4495c218be56": {
"match": "brand_token",
"title": "VIGAFYDE (VIGABATRIN) SOLUTION [UPSHER-SMITH LABORATORIES, LLC]",
"spl_version": "19",
"published_date": "2026-03-02"
}
},
"productid": "80789-003_43aeb38a-b4ee-47ed-8239-c488b074f1c9",
"productndc": "80789-003",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "217684",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "100MG/ML",
"product_no": "001",
"approval_date": "Jun 17, 2024"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VIGABATRIN",
"shortage_reason": "Vigabatrin Oral Solution",
"shortage_status": "current",
"proprietary_name": "VIGAFYDE",
"active_ingred_unit": "mg/mL",
"application_number": "NDA217684",
"marketing_category": "NDA",
"nonproprietary_name": "vigabatrin",
"start_marketing_date": "20240618",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N03AG04.
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