phenytek

Generic: extended phenytoin sodium

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenytek
Generic Name extended phenytoin sodium
Labeler coupler llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

phenytoin sodium 200 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1486
Product ID 67046-1486_2cdc1905-8ef2-1275-e063-6394a90a2ab7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040298
Listing Expiration 2026-12-31
Marketing Start 2025-01-29

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 670461486
Hyphenated Format 67046-1486

Supplemental Identifiers

RxCUI
855861 855863
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 phenytek (source: ndc)
Generic Name extended phenytoin sodium (source: ndc)
Application Number ANDA040298 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-1486-3)
source: ndc

Packages (1)

67046-1486-3 30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-1486-3)

Ingredients (1)

phenytoin sodium (200 mg/1)

Linked Drug Pages (1)

Phenytek ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2cdc1905-8ef2-1275-e063-6394a90a2ab7", "openfda": {"unii": ["4182431BJH"], "rxcui": ["855861", "855863"], "spl_set_id": ["2cdc1905-8f45-1275-e063-6394a90a2ab7"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-1486-3)", "package_ndc": "67046-1486-3", "marketing_start_date": "20250129"}], "brand_name": "Phenytek", "product_id": "67046-1486_2cdc1905-8ef2-1275-e063-6394a90a2ab7", "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": "67046-1486", "generic_name": "extended phenytoin sodium", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenytek", "active_ingredients": [{"name": "PHENYTOIN SODIUM", "strength": "200 mg/1"}], "application_number": "ANDA040298", "marketing_category": "ANDA", "marketing_start_date": "20250129", "listing_expiration_date": "20261231"}