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United States · US · US:67046-0585_51b655cf-3f3d-bc96-e063-6394a90a6954
Phenytoin Sodium
Orange BookUNIISPLATC N03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCoupler LLC
CountryUS (United States)
ATC codeN03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11670460585330 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-0585-3)
Annotations
UNII (FDA Substance ID)
4182431BJH
PHENYTOIN SODIUM
RxCUI 71227
Orange Book
A040684
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": "67046-0585_51b655cf-3f3d-bc96-e063-6394a90a6954",
"productndc": "67046-0585",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "040684",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG EXTENDED",
"product_no": "001",
"approval_date": "Sep 5, 2006"
}
],
"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": "ANDA040684",
"marketing_category": "ANDA",
"nonproprietary_name": "Phenytoin Sodium",
"start_marketing_date": "20260513",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N03AB02.
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