fosphenytoin sodium (68462-945)

Drug Facts

Product Profile

Brand Name fosphenytoin sodium

Generic Name fosphenytoin sodium

Labeler glenmark pharmaceuticals inc., usa

Dosage Form INJECTION, SOLUTION

Routes

INTRAMUSCULAR INTRAVENOUS

Active Ingredients

fosphenytoin sodium 50 mg/mL

Manufacturer

GLENMARK PHARMACEUTICALS INC., USA

Identifiers & Regulatory

Product NDC 68462-945

Product ID 68462-945_2dead4d5-7696-4cf9-b8dc-5d10da310df3

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA214926

Listing Expiration 2027-12-31

Marketing Start 2025-05-28

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 68462945

Hyphenated Format 68462-945

Supplemental Identifiers

RxCUI

1670195

UPC

0368462945643

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

10 VIAL, SINGLE-DOSE in 1 CARTON (68462-945-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68462-945-64)

source: ndc

Packages (1)

68462-945-10 10 VIAL, SINGLE-DOSE in 1 CARTON (68462-945-10) / 10 mL in 1 VIAL, SINGLE-DOSE (68462-945-64)

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": "2dead4d5-7696-4cf9-b8dc-5d10da310df3", "openfda": {"upc": ["0368462945643"], "unii": ["7VLR55452Z"], "rxcui": ["1670195"], "spl_set_id": ["bb38bc6a-99c7-4cda-b3f0-37f629d060cf"], "manufacturer_name": ["GLENMARK PHARMACEUTICALS INC., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (68462-945-10)  / 10 mL in 1 VIAL, SINGLE-DOSE (68462-945-64)", "package_ndc": "68462-945-10", "marketing_start_date": "20250528"}], "brand_name": "Fosphenytoin sodium", "product_id": "68462-945_2dead4d5-7696-4cf9-b8dc-5d10da310df3", "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": "68462-945", "generic_name": "Fosphenytoin sodium", "labeler_name": "GLENMARK PHARMACEUTICALS INC., USA", "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": "20250528", "listing_expiration_date": "20271231"}