🇺🇸
United States · US · US:68083-461_00f57b3c-3819-440e-a928-eeec0fee27aa
Fosphenytoin sodium
Orange BookUNIISPLATC N03AB05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGland Pharma Limited
CountryUS (United States)
ATC codeN03AB05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11680834611010 VIAL, SINGLE-DOSE in 1 CARTON (68083-461-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68083-461-01)
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": "68083-461_00f57b3c-3819-440e-a928-eeec0fee27aa",
"productndc": "68083-461",
"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": "20231013",
"active_numerator_strength": "50"
}Related drugs
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- 🇺🇸Fosphenytoin sodiumGland Pharma Limited
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