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United States · US · US:61919-815_4bd28a50-22df-5238-e063-6294a90a6eec
PHENYTOIN SODIUM
Orange BookUNIISPLATC N03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDIRECT RX
CountryUS (United States)
ATC codeN03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc11619198153030 CAPSULE in 1 BOTTLE (61919-815-30)
- ndc116191981571100 CAPSULE in 1 BOTTLE (61919-815-71)
- ndc116191981572120 CAPSULE in 1 BOTTLE (61919-815-72)
Annotations
UNII (FDA Substance ID)
4182431BJH
PHENYTOIN SODIUM
RxCUI 71227
Orange Book
A040765
AB
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": "61919-815_4bd28a50-22df-5238-e063-6294a90a6eec",
"productndc": "61919-815",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "040765",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG EXTENDED",
"product_no": "001",
"approval_date": "Nov 12, 2008"
}
],
"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": "ANDA040765",
"marketing_category": "ANDA",
"nonproprietary_name": "PHENYTOIN SODIUM",
"start_marketing_date": "20140101",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N03AB02.
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