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United States · US · US:58151-115_f339f9e4-b289-4efe-82b9-46c57d1dc277
Dilantin-125
Orange BookUNIISPLATC N03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerViatris Specialty LLC
CountryUS (United States)
ATC codeN03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1158151115351 BOTTLE, PLASTIC in 1 CARTON (58151-115-35) / 237 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
6158TKW0C5
PHENYTOIN
RxCUI 8183
Orange Book
N008762
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "6158TKW0C5",
"rxcui": "8183",
"inchikey": "CXOFVDLJLONNDW-UHFFFAOYSA-N",
"display_name": "PHENYTOIN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"f339f9e4-b289-4efe-82b9-46c57d1dc277": {
"match": "brand_token",
"title": "DILANTIN-125 (PHENYTOIN) SUSPENSION [VIATRIS SPECIALTY LLC]",
"spl_version": "1",
"published_date": "2024-04-22"
}
},
"productid": "58151-115_f339f9e4-b289-4efe-82b9-46c57d1dc277",
"productndc": "58151-115",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "008762",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "125MG/5ML",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "30MG/5ML",
"product_no": "002",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PHENYTOIN",
"proprietary_name": "Dilantin-125",
"active_ingred_unit": "mg/5mL",
"application_number": "NDA008762",
"marketing_category": "NDA",
"nonproprietary_name": "Phenytoin",
"start_marketing_date": "20240419",
"active_numerator_strength": "125"
}Related drugs
Other records sharing ATC code N03AB02.
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