cerebyx

Generic: fosphenytoin sodium

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cerebyx
Generic Name fosphenytoin sodium
Labeler pfizer laboratories div pfizer inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

fosphenytoin sodium 50 mg/mL

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-6001
Product ID 0069-6001_c2767f24-e5ac-4d94-8bff-faf0a6eaf7c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020450
Listing Expiration 2026-12-31
Marketing Start 2013-10-28

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 00696001
Hyphenated Format 0069-6001

Supplemental Identifiers

RxCUI
1670195 1670197 1670200 1670201
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 cerebyx (source: ndc)
Generic Name fosphenytoin sodium (source: ndc)
Application Number NDA020450 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 PACKAGE (0069-6001-21) / 10 mL in 1 VIAL (0069-6001-10)
  • 25 VIAL in 1 CARTON (0069-6001-25) / 2 mL in 1 VIAL (0069-6001-02)
source: ndc

Packages (2)

0069-6001-21 10 VIAL in 1 PACKAGE (0069-6001-21) / 10 mL in 1 VIAL (0069-6001-10) 0069-6001-25 25 VIAL in 1 CARTON (0069-6001-25) / 2 mL in 1 VIAL (0069-6001-02)

Ingredients (1)

fosphenytoin sodium (50 mg/mL)

Linked Drug Pages (1)

CEREBYX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "c2767f24-e5ac-4d94-8bff-faf0a6eaf7c4", "openfda": {"unii": ["7VLR55452Z"], "rxcui": ["1670195", "1670197", "1670200", "1670201"], "spl_set_id": ["d4c36fad-0ba2-4cd4-9c5e-dcf843f38a5a"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 PACKAGE (0069-6001-21)  / 10 mL in 1 VIAL (0069-6001-10)", "package_ndc": "0069-6001-21", "marketing_start_date": "20131028"}, {"sample": false, "description": "25 VIAL in 1 CARTON (0069-6001-25)  / 2 mL in 1 VIAL (0069-6001-02)", "package_ndc": "0069-6001-25", "marketing_start_date": "20131028"}], "brand_name": "CEREBYX", "product_id": "0069-6001_c2767f24-e5ac-4d94-8bff-faf0a6eaf7c4", "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": "0069-6001", "generic_name": "Fosphenytoin Sodium", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CEREBYX", "active_ingredients": [{"name": "FOSPHENYTOIN SODIUM", "strength": "50 mg/mL"}], "application_number": "NDA020450", "marketing_category": "NDA", "marketing_start_date": "20131028", "listing_expiration_date": "20261231"}