fosphenytoin

Generic: fosphenytoin sodium

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fosphenytoin
Generic Name fosphenytoin sodium
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

fosphenytoin sodium 50 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-403
Product ID 63323-403_84385df0-4793-47d2-8e49-5c84668a0ba3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078052
Listing Expiration 2026-12-31
Marketing Start 2009-12-14

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 63323403
Hyphenated Format 63323-403

Supplemental Identifiers

RxCUI
1670195 1670200
UPC
0363323403010 0363323403041
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 (source: ndc)
Generic Name fosphenytoin sodium (source: ndc)
Application Number ANDA078052 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 TRAY (63323-403-02) / 2 mL in 1 VIAL (63323-403-01)
  • 10 VIAL in 1 TRAY (63323-403-10) / 10 mL in 1 VIAL (63323-403-04)
source: ndc

Packages (2)

63323-403-02 25 VIAL in 1 TRAY (63323-403-02) / 2 mL in 1 VIAL (63323-403-01) 63323-403-10 10 VIAL in 1 TRAY (63323-403-10) / 10 mL in 1 VIAL (63323-403-04)

Ingredients (1)

fosphenytoin sodium (50 mg/mL)

Linked Drug Pages (1)

Fosphenytoin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "84385df0-4793-47d2-8e49-5c84668a0ba3", "openfda": {"upc": ["0363323403010", "0363323403041"], "unii": ["7VLR55452Z"], "rxcui": ["1670195", "1670200"], "spl_set_id": ["b60c9c82-e5c7-4e05-98c7-5bbba4af04b2"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 TRAY (63323-403-02)  / 2 mL in 1 VIAL (63323-403-01)", "package_ndc": "63323-403-02", "marketing_start_date": "20091214"}, {"sample": false, "description": "10 VIAL in 1 TRAY (63323-403-10)  / 10 mL in 1 VIAL (63323-403-04)", "package_ndc": "63323-403-10", "marketing_start_date": "20091214"}], "brand_name": "Fosphenytoin", "product_id": "63323-403_84385df0-4793-47d2-8e49-5c84668a0ba3", "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": "63323-403", "generic_name": "FOSPHENYTOIN SODIUM", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fosphenytoin", "active_ingredients": [{"name": "FOSPHENYTOIN SODIUM", "strength": "50 mg/mL"}], "application_number": "ANDA078052", "marketing_category": "ANDA", "marketing_start_date": "20091214", "listing_expiration_date": "20261231"}