dilantin infatabs (0071-0007)

Drug Facts

Product Profile

Brand Name dilantin infatabs

Generic Name phenytoin

Labeler parke-davis div of pfizer inc

Dosage Form TABLET, CHEWABLE

Routes

ORAL

Active Ingredients

phenytoin 50 mg/1

Manufacturer

Parke-Davis Div of Pfizer Inc

Identifiers & Regulatory

Product NDC 0071-0007

Product ID 0071-0007_470b61a6-09e1-45d0-8b65-b77cec9ba9c3

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA084427

Listing Expiration 2027-12-31

Marketing Start 1979-02-26

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 00710007

Hyphenated Format 0071-0007

Supplemental Identifiers

RxCUI

1313885 1313887

UPC

0300710007246

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 dilantin 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 (0071-0007-24)

source: ndc

Packages (1)

0071-0007-24 100 TABLET, CHEWABLE in 1 BOTTLE (0071-0007-24)

Ingredients (1)

phenytoin (50 mg/1)

Linked Drug Pages (1)

Dilantin Infatabs ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "470b61a6-09e1-45d0-8b65-b77cec9ba9c3", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000191266", "N0000187064", "N0000187063", "N0000185607", "N0000191267", "N0000190118", "N0000185507"], "upc": ["0300710007246"], "unii": ["6158TKW0C5"], "rxcui": ["1313885", "1313887"], "spl_set_id": ["ca119a89-2394-4d34-8078-cd1fa4e8e2f1"], "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": ["Parke-Davis Div of Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, CHEWABLE in 1 BOTTLE (0071-0007-24)", "package_ndc": "0071-0007-24", "marketing_start_date": "19790226"}], "brand_name": "Dilantin Infatabs", "product_id": "0071-0007_470b61a6-09e1-45d0-8b65-b77cec9ba9c3", "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": "0071-0007", "generic_name": "Phenytoin", "labeler_name": "Parke-Davis Div of Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dilantin Infatabs", "active_ingredients": [{"name": "PHENYTOIN", "strength": "50 mg/1"}], "application_number": "ANDA084427", "marketing_category": "ANDA", "marketing_start_date": "19790226", "listing_expiration_date": "20271231"}