phenytoin sodium

Generic: phenytoin sodium

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenytoin sodium
Generic Name phenytoin sodium
Labeler major pharmaceuticals
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

phenytoin sodium 100 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7416
Product ID 0904-7416_46d5c0d1-a97b-46d9-8cf4-994780673337
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040684
Listing Expiration 2026-12-31
Marketing Start 2025-12-09

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 09047416
Hyphenated Format 0904-7416

Supplemental Identifiers

RxCUI
855671
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 ANDA040684 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7416-61) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7416-61 100 BLISTER PACK in 1 CARTON (0904-7416-61) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK

Ingredients (1)

phenytoin sodium (100 mg/1)

Linked Drug Pages (1)

Phenytoin Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "46d5c0d1-a97b-46d9-8cf4-994780673337", "openfda": {"unii": ["4182431BJH"], "rxcui": ["855671"], "spl_set_id": ["46d5c0d1-a97b-46d9-8cf4-994780673337"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7416-61)  / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK", "package_ndc": "0904-7416-61", "marketing_start_date": "20251209"}], "brand_name": "Phenytoin Sodium", "product_id": "0904-7416_46d5c0d1-a97b-46d9-8cf4-994780673337", "dosage_form": "CAPSULE, EXTENDED RELEASE", "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": "0904-7416", "generic_name": "Phenytoin Sodium", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenytoin Sodium", "active_ingredients": [{"name": "PHENYTOIN SODIUM", "strength": "100 mg/1"}], "application_number": "ANDA040684", "marketing_category": "ANDA", "marketing_start_date": "20251209", "listing_expiration_date": "20261231"}