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United States · US · US:51672-4146_4e03fb7d-d33a-2472-e063-6394a90a9b81
Phenytoin
Orange BookUNIISPLATC N03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeN03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc115167241461100 TABLET, CHEWABLE in 1 BOTTLE (51672-4146-1)
- ndc1151672414631000 TABLET, CHEWABLE in 1 BOTTLE (51672-4146-3)
- ndc11516724146630 TABLET, CHEWABLE in 1 BOTTLE (51672-4146-6)
Annotations
UNII (FDA Substance ID)
6158TKW0C5
PHENYTOIN
RxCUI 8183
Orange Book
A200565
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": "51672-4146_4e03fb7d-d33a-2472-e063-6394a90a9b81",
"productndc": "51672-4146",
"dosage_form": "TABLET, CHEWABLE",
"orange_book": {
"appl_no": "200565",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Apr 17, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PHENYTOIN",
"proprietary_name": "Phenytoin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA200565",
"marketing_category": "ANDA",
"nonproprietary_name": "Phenytoin",
"start_marketing_date": "20140417",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N03AB02.
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