phenytoin sodium

Generic: phenytoin sodium

Labeler: henry schein, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenytoin sodium
Generic Name phenytoin sodium
Labeler henry schein, inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

phenytoin sodium 50 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9808
Product ID 0404-9808_5e1a40d6-bf15-4ec2-a12a-cb8ac1116ffb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084307
Listing Expiration 2026-12-31
Marketing Start 2024-12-26

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 04049808
Hyphenated Format 0404-9808

Supplemental Identifiers

RxCUI
1670353
UNII
4182431BJH

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 phenytoin sodium (source: ndc)
Generic Name phenytoin sodium (source: ndc)
Application Number ANDA084307 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 BAG (0404-9808-05) / 5 mL in 1 VIAL
source: ndc

Packages (1)

0404-9808-05 1 VIAL in 1 BAG (0404-9808-05) / 5 mL in 1 VIAL

Ingredients (1)

phenytoin sodium (50 mg/mL)

Linked Drug Pages (1)

PHENYTOIN SODIUM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "5e1a40d6-bf15-4ec2-a12a-cb8ac1116ffb", "openfda": {"unii": ["4182431BJH"], "rxcui": ["1670353"], "spl_set_id": ["a52cf1bd-dc1f-47be-aba8-29066d9a50fb"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BAG (0404-9808-05)  / 5 mL in 1 VIAL", "package_ndc": "0404-9808-05", "marketing_start_date": "20241226"}], "brand_name": "PHENYTOIN SODIUM", "product_id": "0404-9808_5e1a40d6-bf15-4ec2-a12a-cb8ac1116ffb", "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": "0404-9808", "generic_name": "phenytoin sodium", "labeler_name": "Henry Schein, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PHENYTOIN SODIUM", "active_ingredients": [{"name": "PHENYTOIN SODIUM", "strength": "50 mg/mL"}], "application_number": "ANDA084307", "marketing_category": "ANDA", "marketing_start_date": "20241226", "listing_expiration_date": "20261231"}