phenytoin sodium

Generic: phenytoin sodium

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenytoin sodium
Generic Name phenytoin sodium
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

phenytoin sodium 50 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0641-0493
Product ID 0641-0493_1b68e42c-ebb1-4798-adba-712a41cd1cf4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084307
Listing Expiration 2026-12-31
Marketing Start 1975-07-16

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 06410493
Hyphenated Format 0641-0493

Supplemental Identifiers

RxCUI
1670351 1670353
UPC
0306410493259
UNII
4182431BJH

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 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
  • 25 VIAL in 1 CARTON (0641-0493-25) / 2 mL in 1 VIAL (0641-0493-21)
source: ndc

Packages (1)

0641-0493-25 25 VIAL in 1 CARTON (0641-0493-25) / 2 mL in 1 VIAL (0641-0493-21)

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": "1b68e42c-ebb1-4798-adba-712a41cd1cf4", "openfda": {"upc": ["0306410493259"], "unii": ["4182431BJH"], "rxcui": ["1670351", "1670353"], "spl_set_id": ["035a8d4e-2063-4240-83cb-d7eebcabe301"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (0641-0493-25)  / 2 mL in 1 VIAL (0641-0493-21)", "package_ndc": "0641-0493-25", "marketing_start_date": "19750716"}], "brand_name": "Phenytoin Sodium", "product_id": "0641-0493_1b68e42c-ebb1-4798-adba-712a41cd1cf4", "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": "0641-0493", "generic_name": "Phenytoin Sodium", "labeler_name": "Hikma Pharmaceuticals USA 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": "19750716", "listing_expiration_date": "20261231"}