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United States · US · US:64980-573_14ec4c18-fa7a-46e6-ac18-a7c23253e51c
Phenytoin
Orange BookUNIISPLATC N03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeN03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116498057301100 TABLET, CHEWABLE in 1 BOTTLE (64980-573-01)
Annotations
UNII (FDA Substance ID)
6158TKW0C5
PHENYTOIN
RxCUI 8183
Orange Book
A200691
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": "64980-573_14ec4c18-fa7a-46e6-ac18-a7c23253e51c",
"productndc": "64980-573",
"dosage_form": "TABLET, CHEWABLE",
"orange_book": {
"appl_no": "200691",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Dec 26, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PHENYTOIN",
"proprietary_name": "Phenytoin",
"active_ingred_unit": "mg/1",
"application_number": "ANDA200691",
"marketing_category": "ANDA",
"nonproprietary_name": "Phenytoin",
"start_marketing_date": "20240503",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N03AB02.
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