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United States · US · US:66993-372_7cdde2aa-57b2-49e4-8563-bbe86f67cd39
Phenytoin Infatabs
Orange BookUNIISPLATC N03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPrasco Laboratories
CountryUS (United States)
ATC codeN03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116699337202100 TABLET, CHEWABLE in 1 BOTTLE (66993-372-02)
Annotations
UNII (FDA Substance ID)
6158TKW0C5
PHENYTOIN
RxCUI 8183
Orange Book
A084427
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": "66993-372_7cdde2aa-57b2-49e4-8563-bbe86f67cd39",
"productndc": "66993-372",
"dosage_form": "TABLET, CHEWABLE",
"orange_book": {
"appl_no": "084427",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "50MG",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PHENYTOIN",
"proprietary_name": "Phenytoin Infatabs",
"active_ingred_unit": "mg/1",
"application_number": "ANDA084427",
"marketing_category": "ANDA",
"nonproprietary_name": "Phenytoin",
"start_marketing_date": "20211123",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N03AB02.
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