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United States · US · US:0378-2670_a532ea94-0186-4554-969c-66ff80f95c94
Phenytek
Orange BookUNIISPLATC N03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc110378267001100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-2670-01)
- ndc11037826709330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-2670-93)
Annotations
UNII (FDA Substance ID)
4182431BJH
PHENYTOIN SODIUM
RxCUI 71227
Orange Book
A040298
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": {
"2cdc1905-8f45-1275-e063-6394a90a2ab7": {
"match": "brand_token",
"title": "PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [COUPLER LLC]",
"spl_version": "1",
"published_date": "2025-01-30"
}
},
"productid": "0378-2670_a532ea94-0186-4554-969c-66ff80f95c94",
"productndc": "0378-2670",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "040298",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "100MG EXTENDED",
"product_no": "001",
"approval_date": "Dec 28, 1998"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "200MG EXTENDED",
"product_no": "002",
"approval_date": "Dec 6, 2001"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "300MG EXTENDED",
"product_no": "003",
"approval_date": "Dec 6, 2001"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "PHENYTOIN SODIUM",
"proprietary_name": "Phenytek",
"active_ingred_unit": "mg/1",
"application_number": "ANDA040298",
"marketing_category": "ANDA",
"nonproprietary_name": "extended phenytoin sodium",
"start_marketing_date": "20011210",
"active_numerator_strength": "200"
}Related drugs
Other records sharing ATC code N03AB02.
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