fosphenytoin sodium

Generic: fosphenytoin sodium

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fosphenytoin sodium
Generic Name fosphenytoin sodium
Labeler amneal pharmaceuticals llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

fosphenytoin sodium 50 mg/mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-998
Product ID 65162-998_757ffbac-e93f-4e0c-b3d2-0d29179b174b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078476
Listing Expiration 2026-12-31
Marketing Start 2013-05-17

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 65162998
Hyphenated Format 65162-998

Supplemental Identifiers

RxCUI
1670195 1670200
UPC
0365162999013 0365162998016
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 ANDA078476 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (65162-998-25) / 2 mL in 1 VIAL (65162-998-01)
source: ndc

Packages (1)

65162-998-25 25 VIAL in 1 CARTON (65162-998-25) / 2 mL in 1 VIAL (65162-998-01)

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": "757ffbac-e93f-4e0c-b3d2-0d29179b174b", "openfda": {"upc": ["0365162999013", "0365162998016"], "unii": ["7VLR55452Z"], "rxcui": ["1670195", "1670200"], "spl_set_id": ["87ff8a91-5b37-401c-b75c-dc6efd348761"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (65162-998-25)  / 2 mL in 1 VIAL (65162-998-01)", "package_ndc": "65162-998-25", "marketing_start_date": "20130517"}], "brand_name": "Fosphenytoin Sodium", "product_id": "65162-998_757ffbac-e93f-4e0c-b3d2-0d29179b174b", "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": "65162-998", "generic_name": "Fosphenytoin Sodium", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fosphenytoin Sodium", "active_ingredients": [{"name": "FOSPHENYTOIN SODIUM", "strength": "50 mg/mL"}], "application_number": "ANDA078476", "marketing_category": "ANDA", "marketing_start_date": "20130517", "listing_expiration_date": "20261231"}