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United States · US · US:42192-614_ae14cce7-f65a-45e0-8ff4-9388d0a806d2
PHENYTOIN SODIUM
Orange BookUNIISPLATC N03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAcella Pharmaceuticals, LLC
CountryUS (United States)
ATC codeN03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11421926141010 VIAL in 1 CARTON (42192-614-10) / 2 mL in 1 VIAL
- ndc11421926143010 VIAL in 1 CARTON (42192-614-30) / 5 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
4182431BJH
PHENYTOIN SODIUM
RxCUI 71227
Orange Book
A040573
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": "42192-614_ae14cce7-f65a-45e0-8ff4-9388d0a806d2",
"productndc": "42192-614",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "040573",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "50MG/ML",
"product_no": "001",
"approval_date": "Sep 13, 2006"
}
],
"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": "ANDA040573",
"marketing_category": "ANDA",
"nonproprietary_name": "PHENYTOIN SODIUM",
"start_marketing_date": "20211201",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N03AB02.
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