🇺🇸
United States · US · US:25021-798_20212ecb-248d-4fc6-b88d-c54a18076845
Fosphenytoin Sodium
Orange BookUNIISPLATC N03AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSagent Pharmaceuticals
CountryUS (United States)
ATC codeN03AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11250217980225 VIAL in 1 CARTON (25021-798-02) / 2 mL in 1 VIAL
- ndc11250217981010 VIAL in 1 CARTON (25021-798-10) / 10 mL in 1 VIAL
Annotations
UNII (FDA Substance ID)
7VLR55452Z
FOSPHENYTOIN SODIUM
RxCUI 82806
Orange Book
A214926
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": "25021-798_20212ecb-248d-4fc6-b88d-c54a18076845",
"productndc": "25021-798",
"dosage_form": "INJECTION, SOLUTION",
"orange_book": {
"appl_no": "214926",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AP",
"strength": "EQ 50MG PHENYTOIN NA/ML",
"product_no": "001",
"approval_date": "Oct 13, 2023"
}
],
"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": "ANDA214926",
"marketing_category": "ANDA",
"nonproprietary_name": "Fosphenytoin Sodium",
"start_marketing_date": "20250115",
"active_numerator_strength": "50"
}Related drugs
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