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United States · US · US:51662-1250_ef6a784b-3d13-da51-e053-2a95a90ad05d
PHENYTOIN SODIUM
Orange BookUNIISPLATC N03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHF Acquisition Co LLC, DBA HealthFirst
CountryUS (United States)
ATC codeN03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1151662125015 mL in 1 VIAL, SINGLE-DOSE (51662-1250-1)
Annotations
UNII (FDA Substance ID)
4182431BJH
PHENYTOIN SODIUM
RxCUI 71227
Orange Book
A084307
AP
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": "INTRAMUSCULAR; INTRAVENOUS",
"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": "51662-1250_ef6a784b-3d13-da51-e053-2a95a90ad05d",
"productndc": "51662-1250",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "084307",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AP",
"strength": "50MG/ML",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PHENYTOIN SODIUM",
"proprietary_name": "PHENYTOIN SODIUM",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA084307",
"marketing_category": "ANDA",
"nonproprietary_name": "PHENYTOIN SODIUM",
"start_marketing_date": "20180919",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N03AB02.
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