🇺🇸
United States · US · US:67386-111_09c27a1b-5916-4e16-a9a3-924099661be6
SABRIL
In shortageOrange BookUNIISPLATC N03AG04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLundbeck Pharmaceuticals LLC
CountryUS (United States)
ATC codeN03AG04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116738611101100 TABLET, FILM COATED in 1 BOTTLE (67386-111-01)
Annotations
UNII (FDA Substance ID)
GR120KRT6K
VIGABATRIN
RxCUI 14851
Orange Book
N020427
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": {
"a88ac1b4-e2c9-45c0-b321-4785902172e3": {
"match": "brand_token",
"title": "SABRIL (VIGABATRIN) POWDER, FOR SOLUTION [LUNDBECK PHARMACEUTICALS LLC]",
"spl_version": "46",
"published_date": "2025-12-17"
}
},
"productid": "67386-111_09c27a1b-5916-4e16-a9a3-924099661be6",
"productndc": "67386-111",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "020427",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "500MG",
"product_no": "001",
"approval_date": "Aug 21, 2009"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "VIGABATRIN",
"shortage_reason": "Vigabatrin Oral Solution",
"shortage_status": "current",
"proprietary_name": "SABRIL",
"active_ingred_unit": "mg/1",
"application_number": "NDA020427",
"marketing_category": "NDA",
"nonproprietary_name": "vigabatrin",
"start_marketing_date": "20090821",
"active_numerator_strength": "500"
}Related drugs
Other records sharing ATC code N03AG04.
Access this data programmatically
Query SABRIL 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.