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United States · US · US:67386-211_d2901195-e325-4ca5-8453-b020a77ba6aa
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
- ndc11673862116550 PACKET in 1 CARTON (67386-211-65) / 10 mL in 1 PACKET
Annotations
UNII (FDA Substance ID)
GR120KRT6K
VIGABATRIN
RxCUI 14851
Orange Book
N022006
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": {
"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": "67386-211_d2901195-e325-4ca5-8453-b020a77ba6aa",
"productndc": "67386-211",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "022006",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AA",
"strength": "500MG/PACKET",
"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/mL",
"application_number": "NDA022006",
"marketing_category": "NDA",
"nonproprietary_name": "vigabatrin",
"start_marketing_date": "20090821",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N03AG04.
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