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United States · US · US:0615-8556_8240390a-9bc8-4256-8f2a-107c97c0400c
Extended Phenytoin Sodium
Orange BookUNIISPLATC N03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNCS HealthCare of KY, LLC dba Vangard Labs
CountryUS (United States)
ATC codeN03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11061585563930 CAPSULE in 1 BLISTER PACK (0615-8556-39)
Annotations
UNII (FDA Substance ID)
4182431BJH
PHENYTOIN SODIUM
RxCUI 71227
Orange Book
A204309
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": "0615-8556_8240390a-9bc8-4256-8f2a-107c97c0400c",
"productndc": "0615-8556",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "204309",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "100MG EXTENDED",
"product_no": "001",
"approval_date": "Jun 10, 2015"
}
],
"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": "ANDA204309",
"marketing_category": "ANDA",
"nonproprietary_name": "Phenytoin Sodium",
"start_marketing_date": "20150610",
"active_numerator_strength": "100"
}Related drugs
Other records sharing ATC code N03AB02.
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