phenytoin infatabs

Generic: phenytoin

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenytoin infatabs
Generic Name phenytoin
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

phenytoin 50 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8424
Product ID 0615-8424_44fa2cc3-a26a-4e4d-9087-a196c69d9ca5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084427
Marketing Start 2021-11-23
Marketing End 2026-11-30

Pharmacologic Class

Established (EPC)
anti-epileptic agent [epc]
Mechanism of Action
cytochrome p450 1a2 inducers [moa] cytochrome p450 2b6 inducers [moa] cytochrome p450 2c8 inducers [moa] cytochrome p450 2c19 inducers [moa] cytochrome p450 2d6 inducers [moa] cytochrome p450 3a inducers [moa] cytochrome p450 2c9 inducers [moa]
Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06158424
Hyphenated Format 0615-8424

Supplemental Identifiers

RxCUI
1313885
UNII
6158TKW0C5
NUI
N0000175753 N0000008486 N0000191266 N0000187064 N0000187063 N0000185607 N0000191267 N0000190118 N0000185507

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 infatabs (source: ndc)
Generic Name phenytoin (source: ndc)
Application Number ANDA084427 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8424-39)
source: ndc

Packages (1)

0615-8424-39 30 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8424-39)

Ingredients (1)

phenytoin (50 mg/1)

Linked Drug Pages (1)

Phenytoin Infatabs ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "44fa2cc3-a26a-4e4d-9087-a196c69d9ca5", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000191266", "N0000187064", "N0000187063", "N0000185607", "N0000191267", "N0000190118", "N0000185507"], "unii": ["6158TKW0C5"], "rxcui": ["1313885"], "spl_set_id": ["0d240b2b-bc5c-4989-a20b-54ed37a09a4f"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "pharm_class_epc": ["Anti-epileptic Agent [EPC]"], "pharm_class_moa": ["Cytochrome P450 1A2 Inducers [MoA]", "Cytochrome P450 2B6 Inducers [MoA]", "Cytochrome P450 2C8 Inducers [MoA]", "Cytochrome P450 2C19 Inducers [MoA]", "Cytochrome P450 2D6 Inducers [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Cytochrome P450 2C9 Inducers [MoA]"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, CHEWABLE in 1 BLISTER PACK (0615-8424-39)", "package_ndc": "0615-8424-39", "marketing_end_date": "20261130", "marketing_start_date": "20220201"}], "brand_name": "Phenytoin Infatabs", "product_id": "0615-8424_44fa2cc3-a26a-4e4d-9087-a196c69d9ca5", "dosage_form": "TABLET, CHEWABLE", "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": "0615-8424", "generic_name": "Phenytoin", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenytoin Infatabs", "active_ingredients": [{"name": "PHENYTOIN", "strength": "50 mg/1"}], "application_number": "ANDA084427", "marketing_category": "ANDA", "marketing_end_date": "20261130", "marketing_start_date": "20211123"}