🇺🇸
United States · US · US:63323-403_84385df0-4793-47d2-8e49-5c84668a0ba3
Fosphenytoin
Orange BookUNIISPLATC N03AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeN03AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11633234030225 VIAL in 1 TRAY (63323-403-02) / 2 mL in 1 VIAL (63323-403-01)
- ndc11633234031010 VIAL in 1 TRAY (63323-403-10) / 10 mL in 1 VIAL (63323-403-04)
Annotations
UNII (FDA Substance ID)
7VLR55452Z
FOSPHENYTOIN SODIUM
RxCUI 82806
Orange Book
A078052
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "7VLR55452Z",
"rxcui": "82806",
"inchikey": "GQPXYJNXTAFDLT-UHFFFAOYSA-L",
"display_name": "FOSPHENYTOIN SODIUM",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "INTRAMUSCULAR; INTRAVENOUS",
"spl_meta": {
"bb38bc6a-99c7-4cda-b3f0-37f629d060cf": {
"match": "brand_token",
"title": "FOSPHENYTOIN SODIUM INJECTION, SOLUTION [GLENMARK PHARMACEUTICALS INC., USA]",
"spl_version": "3",
"published_date": "2026-03-23"
}
},
"productid": "63323-403_84385df0-4793-47d2-8e49-5c84668a0ba3",
"productndc": "63323-403",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "078052",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 50MG PHENYTOIN NA/ML",
"product_no": "001",
"approval_date": "Aug 6, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FOSPHENYTOIN SODIUM",
"proprietary_name": "Fosphenytoin",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA078052",
"marketing_category": "ANDA",
"nonproprietary_name": "FOSPHENYTOIN SODIUM",
"start_marketing_date": "20091214",
"active_numerator_strength": "50"
}Related drugs
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