fosphenytoin sodium

Generic: fosphenytoin sodium

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fosphenytoin sodium
Generic Name fosphenytoin sodium
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

fosphenytoin sodium 50 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-460
Product ID 68083-460_00f57b3c-3819-440e-a928-eeec0fee27aa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214926
Listing Expiration 2026-12-31
Marketing Start 2023-10-13

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 68083460
Hyphenated Format 68083-460

Supplemental Identifiers

RxCUI
1670195 1670200
UPC
0368083461010 0368083461102 0368083460259
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, SINGLE-DOSE in 1 CARTON (68083-460-25) / 2 mL in 1 VIAL, SINGLE-DOSE (68083-460-01)
source: ndc

Packages (1)

68083-460-25 25 VIAL, SINGLE-DOSE in 1 CARTON (68083-460-25) / 2 mL in 1 VIAL, SINGLE-DOSE (68083-460-01)

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": "00f57b3c-3819-440e-a928-eeec0fee27aa", "openfda": {"upc": ["0368083461010", "0368083461102", "0368083460259"], "unii": ["7VLR55452Z"], "rxcui": ["1670195", "1670200"], "spl_set_id": ["49b08648-6a83-42c7-ae7b-80c29f2534fc"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (68083-460-25)  / 2 mL in 1 VIAL, SINGLE-DOSE (68083-460-01)", "package_ndc": "68083-460-25", "marketing_start_date": "20231013"}], "brand_name": "Fosphenytoin sodium", "product_id": "68083-460_00f57b3c-3819-440e-a928-eeec0fee27aa", "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": "68083-460", "generic_name": "Fosphenytoin sodium", "labeler_name": "Gland Pharma Limited", "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": "20231013", "listing_expiration_date": "20261231"}