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United States · US · US:0641-6138_8c2cd4dc-57c1-48b8-8005-95c5a5593e7c
Phenytoin Sodium
Orange BookUNIISPLATC N03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeN03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11064161382525 VIAL in 1 CARTON (0641-6138-25) / 2 mL in 1 VIAL (0641-6138-01)
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": "0641-6138_8c2cd4dc-57c1-48b8-8005-95c5a5593e7c",
"productndc": "0641-6138",
"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": "19750716",
"active_numerator_strength": "50"
}Related drugs
Other records sharing ATC code N03AB02.
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