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United States · US · US:59762-0531_212141a3-fffd-49e0-96d5-57cc921a99d1
Phenytoin
Orange BookUNIISPLATC N03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1159762053121 BOTTLE, PLASTIC in 1 CARTON (59762-0531-2) / 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": {
"3580e6a8-f7c3-44a0-a1eb-2a84ae589d21": {
"match": "brand_token",
"title": "PHENYTOIN INFATABS (PHENYTOIN) TABLET, CHEWABLE [PRASCO LABORATORIES]",
"spl_version": "7",
"published_date": "2026-06-01"
}
},
"productid": "59762-0531_212141a3-fffd-49e0-96d5-57cc921a99d1",
"productndc": "59762-0531",
"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": "Phenytoin",
"active_ingred_unit": "mg/5mL",
"application_number": "NDA008762",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Phenytoin",
"start_marketing_date": "20200422",
"active_numerator_strength": "125"
}Related drugs
Other records sharing ATC code N03AB02.
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