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United States · US · US:43598-697_108f12cf-4bfc-4406-1d50-d57e656f6c8c
Vigabatrin
In shortageOrange BookUNIISPLATC N03AG04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr. Reddy�s Laboratories Inc.,
CountryUS (United States)
ATC codeN03AG04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11435986975050 PACKET in 1 CARTON (43598-697-50) / 10 mL in 1 PACKET (43598-697-11)
Annotations
UNII (FDA Substance ID)
GR120KRT6K
VIGABATRIN
RxCUI 14851
Orange Book
A211481
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": {
"e7cbc0a5-8c28-4451-9176-b608e228ba66": {
"match": "brand_token",
"title": "VIGABATRIN POWDER, FOR SOLUTION [PAR HEALTH USA, LLC]",
"spl_version": "29",
"published_date": "2026-04-23"
}
},
"productid": "43598-697_108f12cf-4bfc-4406-1d50-d57e656f6c8c",
"productndc": "43598-697",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "211481",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "500MG/PACKET",
"product_no": "001",
"approval_date": "Nov 20, 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": "Vigabatrin",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA211481",
"marketing_category": "ANDA",
"nonproprietary_name": "Vigabatrin",
"start_marketing_date": "20181121",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N03AG04.
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