phenytek

Generic: phenytoin sodium

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

Drug Facts

Product Profile

Brand Name phenytek
Generic Name phenytoin sodium
Labeler mylan pharmaceuticals inc.
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

phenytoin sodium 300 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-3750
Product ID 0378-3750_a532ea94-0186-4554-969c-66ff80f95c94
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040298
Listing Expiration 2026-12-31
Marketing Start 2001-12-10

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 03783750
Hyphenated Format 0378-3750

Supplemental Identifiers

RxCUI
855861 855863 855873 855875
UPC
0303783750934 0303782670936
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 phenytek (source: ndc)
Generic Name phenytoin sodium (source: ndc)
Application Number ANDA040298 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-3750-01)
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-3750-93)
source: ndc

Packages (2)

0378-3750-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-3750-01) 0378-3750-93 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-3750-93)

Ingredients (1)

phenytoin sodium (300 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": "a532ea94-0186-4554-969c-66ff80f95c94", "openfda": {"upc": ["0303783750934", "0303782670936"], "unii": ["4182431BJH"], "rxcui": ["855861", "855863", "855873", "855875"], "spl_set_id": ["0f94c791-8b07-4b41-927e-c9f28bec5f60"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-3750-01)", "package_ndc": "0378-3750-01", "marketing_start_date": "20011210"}, {"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-3750-93)", "package_ndc": "0378-3750-93", "marketing_start_date": "20011210"}], "brand_name": "Phenytek", "product_id": "0378-3750_a532ea94-0186-4554-969c-66ff80f95c94", "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": "0378-3750", "generic_name": "phenytoin sodium", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenytek", "active_ingredients": [{"name": "PHENYTOIN SODIUM", "strength": "300 mg/1"}], "application_number": "ANDA040298", "marketing_category": "ANDA", "marketing_start_date": "20011210", "listing_expiration_date": "20261231"}