fosphenytoin sodium

Generic: fosphenytoin sodium

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fosphenytoin sodium
Generic Name fosphenytoin sodium
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

fosphenytoin sodium 50 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-6136
Product ID 0641-6136_d276be92-654c-4912-8dc5-3e148c835523
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077989
Listing Expiration 2026-12-31
Marketing Start 2007-08-06

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 06416136
Hyphenated Format 0641-6136

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 ANDA077989 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (0641-6136-25) / 2 mL in 1 VIAL (0641-6136-01)
source: ndc

Packages (1)

0641-6136-25 25 VIAL in 1 CARTON (0641-6136-25) / 2 mL in 1 VIAL (0641-6136-01)

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": "d276be92-654c-4912-8dc5-3e148c835523", "openfda": {"unii": ["7VLR55452Z"], "rxcui": ["1670195", "1670200"], "spl_set_id": ["519a44e3-8a93-456c-b71c-894513810d45"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (0641-6136-25)  / 2 mL in 1 VIAL (0641-6136-01)", "package_ndc": "0641-6136-25", "marketing_start_date": "20070806"}], "brand_name": "Fosphenytoin Sodium", "product_id": "0641-6136_d276be92-654c-4912-8dc5-3e148c835523", "dosage_form": "INJECTION", "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": "0641-6136", "generic_name": "Fosphenytoin Sodium", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fosphenytoin Sodium", "active_ingredients": [{"name": "FOSPHENYTOIN SODIUM", "strength": "50 mg/mL"}], "application_number": "ANDA077989", "marketing_category": "ANDA", "marketing_start_date": "20070806", "listing_expiration_date": "20261231"}