phenytoin infatabs

Generic: phenytoin

Labeler: prasco laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenytoin infatabs
Generic Name phenytoin
Labeler prasco laboratories
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

phenytoin 50 mg/1

Manufacturer
Prasco Laboratories

Identifiers & Regulatory

Product NDC 66993-372
Product ID 66993-372_e2f4f249-b837-4362-8854-a6c3960e1f94
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA084427
Listing Expiration 2026-12-31
Marketing Start 2021-11-23

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 66993372
Hyphenated Format 66993-372

Supplemental Identifiers

RxCUI
1313885
UPC
0366993372020
UNII
6158TKW0C5
NUI
N0000175753 N0000008486 N0000191266 N0000187064 N0000187063 N0000185607 N0000191267 N0000190118 N0000185507

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 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
  • 100 TABLET, CHEWABLE in 1 BOTTLE (66993-372-02)
source: ndc

Packages (1)

66993-372-02 100 TABLET, CHEWABLE in 1 BOTTLE (66993-372-02)

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": "e2f4f249-b837-4362-8854-a6c3960e1f94", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000191266", "N0000187064", "N0000187063", "N0000185607", "N0000191267", "N0000190118", "N0000185507"], "upc": ["0366993372020"], "unii": ["6158TKW0C5"], "rxcui": ["1313885"], "spl_set_id": ["3580e6a8-f7c3-44a0-a1eb-2a84ae589d21"], "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": ["Prasco Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, CHEWABLE in 1 BOTTLE (66993-372-02)", "package_ndc": "66993-372-02", "marketing_start_date": "20211123"}], "brand_name": "Phenytoin Infatabs", "product_id": "66993-372_e2f4f249-b837-4362-8854-a6c3960e1f94", "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": "66993-372", "generic_name": "Phenytoin", "labeler_name": "Prasco Laboratories", "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_start_date": "20211123", "listing_expiration_date": "20261231"}