🇺🇸
United States · US · US:0143-9782_6b56fe59-9fb1-410b-b57c-7ada1662136a
Fosphenytoin Sodium
Orange BookUNIISPLATC N03AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWest-Ward Pharmaceuticals Corp
CountryUS (United States)
ATC codeN03AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11014397821010 VIAL in 1 PACKAGE (0143-9782-10) / 10 mL in 1 VIAL (0143-9782-01)
Annotations
UNII (FDA Substance ID)
7VLR55452Z
FOSPHENYTOIN SODIUM
RxCUI 82806
Orange Book
A078765
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": "0143-9782_6b56fe59-9fb1-410b-b57c-7ada1662136a",
"productndc": "0143-9782",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "078765",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 50MG PHENYTOIN NA/ML",
"product_no": "001",
"approval_date": "Dec 2, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "FOSPHENYTOIN SODIUM",
"proprietary_name": "Fosphenytoin Sodium",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA078765",
"marketing_category": "ANDA",
"nonproprietary_name": "Fosphenytoin Sodium",
"start_marketing_date": "20091202",
"active_numerator_strength": "50"
}Related drugs
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