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United States · US · US:50090-3539_ea19ae9c-7263-48a1-88d5-e29ec91c6792
Phenytoin Sodium
Orange BookUNIISPLATC N03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeN03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc115009035390100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-3539-0)
- ndc11500903539190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-3539-1)
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": "50090-3539_ea19ae9c-7263-48a1-88d5-e29ec91c6792",
"productndc": "50090-3539",
"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": "20060905",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N03AB02.
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