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United States · US · US:0121-0892_4daa397f-237b-4327-91bd-d86b19e4b9b2
Phenytoin
Orange BookUNIISPLATC N03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPAI Holdings, LLC dba PAI Pharma
CountryUS (United States)
ATC codeN03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1101210892634 mL in 1 CUP, UNIT-DOSE (0121-0892-63)
Annotations
UNII (FDA Substance ID)
6158TKW0C5
PHENYTOIN
RxCUI 8183
Orange Book
A040521
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": "0121-0892_4daa397f-237b-4327-91bd-d86b19e4b9b2",
"productndc": "0121-0892",
"dosage_form": "SUSPENSION",
"orange_book": {
"appl_no": "040521",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "125MG/5ML",
"product_no": "001",
"approval_date": "Mar 8, 2004"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PHENYTOIN",
"proprietary_name": "Phenytoin",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA040521",
"marketing_category": "ANDA",
"nonproprietary_name": "Phenytoin",
"start_marketing_date": "20040408",
"active_numerator_strength": "125"
}Related drugs
Other records sharing ATC code N03AB02.
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