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United States · US · US:65162-212_c611611f-fb3d-40e8-8c1c-dcb6554aaa41
Extended Phenytoin Sodium
Orange BookUNIISPLATC N03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAmneal Pharmaceuticals LLC
CountryUS (United States)
ATC codeN03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11651622120330 CAPSULE in 1 BOTTLE (65162-212-03)
- ndc116516221210100 CAPSULE in 1 BOTTLE (65162-212-10)
- ndc1165162212111000 CAPSULE in 1 BOTTLE (65162-212-11)
- ndc116516221250500 CAPSULE in 1 BOTTLE (65162-212-50)
Annotations
UNII (FDA Substance ID)
4182431BJH
PHENYTOIN SODIUM
RxCUI 71227
Orange Book
A040765
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": {
"7e467c02-49a0-4b62-b537-430fdfa4f10e": {
"match": "brand_token",
"title": "EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMNEAL PHARMACEUTICALS LLC]",
"spl_version": "27",
"published_date": "2026-05-04"
}
},
"productid": "65162-212_c611611f-fb3d-40e8-8c1c-dcb6554aaa41",
"productndc": "65162-212",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "040765",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG EXTENDED",
"product_no": "001",
"approval_date": "Nov 12, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PHENYTOIN SODIUM",
"proprietary_name": "Extended Phenytoin Sodium",
"active_ingred_unit": "mg/1",
"application_number": "ANDA040765",
"marketing_category": "ANDA",
"nonproprietary_name": "Phenytoin Sodium",
"start_marketing_date": "20091216",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N03AB02.
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