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United States · US · US:29300-379_a6527387-ec89-41a1-b85a-c0fb7b4a7db7
Phenytoin Sodium
Orange BookUNIISPLATC N03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerUnichem Pharmaceuticals (USA), Inc.
CountryUS (United States)
ATC codeN03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc112930037901100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-379-01)
- ndc112930037905500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-379-05)
- ndc1129300379101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-379-10)
Annotations
UNII (FDA Substance ID)
4182431BJH
PHENYTOIN SODIUM
RxCUI 71227
Orange Book
A213834
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "4182431BJH",
"rxcui": "71227",
"inchikey": "FJPYVLNWWICYDW-UHFFFAOYSA-M",
"display_name": "PHENYTOIN SODIUM",
"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": "29300-379_a6527387-ec89-41a1-b85a-c0fb7b4a7db7",
"productndc": "29300-379",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "213834",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "100MG EXTENDED",
"product_no": "001",
"approval_date": "Oct 13, 2022"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PHENYTOIN SODIUM",
"proprietary_name": "Phenytoin Sodium",
"active_ingred_unit": "mg/1",
"application_number": "ANDA213834",
"marketing_category": "ANDA",
"nonproprietary_name": "Phenytoin Sodium",
"start_marketing_date": "20221112",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N03AB02.
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