fosphenytoin sodium

Generic: fosphenytoin sodium

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fosphenytoin sodium
Generic Name fosphenytoin sodium
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

fosphenytoin sodium 50 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-798
Product ID 25021-798_20212ecb-248d-4fc6-b88d-c54a18076845
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214926
Listing Expiration 2026-12-31
Marketing Start 2025-01-15

Pharmacologic Class

Classes
anti-epileptic agent [epc] cytochrome p450 1a2 inducers [moa] cytochrome p450 2b6 inducers [moa] cytochrome p450 2c19 inducers [moa] cytochrome p450 2c8 inducers [moa] cytochrome p450 2c9 inducers [moa] cytochrome p450 2d6 inducers [moa] cytochrome p450 3a inducers [moa] decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021798
Hyphenated Format 25021-798

Supplemental Identifiers

RxCUI
1670195 1670200
UNII
7VLR55452Z

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fosphenytoin sodium (source: ndc)
Generic Name fosphenytoin sodium (source: ndc)
Application Number ANDA214926 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (25021-798-02) / 2 mL in 1 VIAL
  • 10 VIAL in 1 CARTON (25021-798-10) / 10 mL in 1 VIAL
source: ndc

Packages (2)

25021-798-02 25 VIAL in 1 CARTON (25021-798-02) / 2 mL in 1 VIAL 25021-798-10 10 VIAL in 1 CARTON (25021-798-10) / 10 mL in 1 VIAL

Ingredients (1)

fosphenytoin sodium (50 mg/mL)

Linked Drug Pages (1)

Fosphenytoin Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "20212ecb-248d-4fc6-b88d-c54a18076845", "openfda": {"unii": ["7VLR55452Z"], "rxcui": ["1670195", "1670200"], "spl_set_id": ["e1dab8ad-cbf6-4273-92fa-02629de2abde"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (25021-798-02)  / 2 mL in 1 VIAL", "package_ndc": "25021-798-02", "marketing_start_date": "20250115"}, {"sample": false, "description": "10 VIAL in 1 CARTON (25021-798-10)  / 10 mL in 1 VIAL", "package_ndc": "25021-798-10", "marketing_start_date": "20250115"}], "brand_name": "Fosphenytoin Sodium", "product_id": "25021-798_20212ecb-248d-4fc6-b88d-c54a18076845", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Anti-epileptic Agent [EPC]", "Cytochrome P450 1A2 Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 2C19 Inducers [MoA]", "Cytochrome P450 2C8 Inducers [MoA]", "Cytochrome P450 2C9 Inducers [MoA]", "Cytochrome P450 2D6 Inducers [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "25021-798", "generic_name": "Fosphenytoin Sodium", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fosphenytoin Sodium", "active_ingredients": [{"name": "FOSPHENYTOIN SODIUM", "strength": "50 mg/mL"}], "application_number": "ANDA214926", "marketing_category": "ANDA", "marketing_start_date": "20250115", "listing_expiration_date": "20261231"}