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United States · US · US:70518-4325_402f06b8-06fa-e2d6-e063-6294a90ad8c9
DILANTIN
Orange BookUNIISPLATC N03AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeN03AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117051843250100 POUCH in 1 BOX (70518-4325-0) / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-4325-1)
Annotations
UNII (FDA Substance ID)
4182431BJH
PHENYTOIN SODIUM
RxCUI 71227
Orange Book
A084349
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": {
"ca119a89-2394-4d34-8078-cd1fa4e8e2f1": {
"match": "brand_token",
"title": "DILANTIN INFATABS (PHENYTOIN) TABLET, CHEWABLE [PARKE-DAVIS DIV OF PFIZER INC]",
"spl_version": "58",
"published_date": "2026-05-21"
}
},
"productid": "70518-4325_402f06b8-06fa-e2d6-e063-6294a90ad8c9",
"productndc": "70518-4325",
"dosage_form": "CAPSULE, EXTENDED RELEASE",
"orange_book": {
"appl_no": "084349",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "30MG EXTENDED",
"product_no": "001",
"approval_date": "Approved Prior to Jan 1, 1982"
},
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "100MG EXTENDED",
"product_no": "002",
"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": "DILANTIN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA084349",
"marketing_category": "ANDA",
"nonproprietary_name": "Extended Phenytoin Sodium",
"start_marketing_date": "20250402",
"active_numerator_strength": "30"
}Related drugs
Other records sharing ATC code N03AB02.
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