fosphenytoin sodium

Generic: fosphenytoin sodium

Labeler: west-ward pharmaceuticals corp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fosphenytoin sodium
Generic Name fosphenytoin sodium
Labeler west-ward pharmaceuticals corp
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

fosphenytoin sodium 50 mg/mL

Manufacturer
West-Ward Pharmaceuticals Corp

Identifiers & Regulatory

Product NDC 0143-9788
Product ID 0143-9788_6b56fe59-9fb1-410b-b57c-7ada1662136a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078765
Listing Expiration 2026-12-31
Marketing Start 2009-12-02

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 01439788
Hyphenated Format 0143-9788

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 ANDA078765 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 PACKAGE (0143-9788-25) / 2 mL in 1 VIAL (0143-9788-01)
source: ndc

Packages (1)

0143-9788-25 25 VIAL in 1 PACKAGE (0143-9788-25) / 2 mL in 1 VIAL (0143-9788-01)

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": "6b56fe59-9fb1-410b-b57c-7ada1662136a", "openfda": {"unii": ["7VLR55452Z"], "rxcui": ["1670195", "1670200"], "spl_set_id": ["c92df63b-5140-4213-8d43-8327ff6230b7"], "manufacturer_name": ["West-Ward Pharmaceuticals Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 PACKAGE (0143-9788-25)  / 2 mL in 1 VIAL (0143-9788-01)", "package_ndc": "0143-9788-25", "marketing_start_date": "20091202"}], "brand_name": "Fosphenytoin Sodium", "product_id": "0143-9788_6b56fe59-9fb1-410b-b57c-7ada1662136a", "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": "0143-9788", "generic_name": "Fosphenytoin Sodium", "labeler_name": "West-Ward Pharmaceuticals Corp", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fosphenytoin Sodium", "active_ingredients": [{"name": "FOSPHENYTOIN SODIUM", "strength": "50 mg/mL"}], "application_number": "ANDA078765", "marketing_category": "ANDA", "marketing_start_date": "20091202", "listing_expiration_date": "20261231"}