phenytoin

Generic: phenytoin

Labeler: rising pharma holdings, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name phenytoin
Generic Name phenytoin
Labeler rising pharma holdings, inc.
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

phenytoin 50 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 64980-573
Product ID 64980-573_14ec4c18-fa7a-46e6-ac18-a7c23253e51c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200691
Listing Expiration 2026-12-31
Marketing Start 2024-05-03

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 64980573
Hyphenated Format 64980-573

Supplemental Identifiers

RxCUI
1313885
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 (source: ndc)
Generic Name phenytoin (source: ndc)
Application Number ANDA200691 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, CHEWABLE in 1 BOTTLE (64980-573-01)
source: ndc

Packages (1)

64980-573-01 100 TABLET, CHEWABLE in 1 BOTTLE (64980-573-01)

Ingredients (1)

phenytoin (50 mg/1)

Linked Drug Pages (1)

Phenytoin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "14ec4c18-fa7a-46e6-ac18-a7c23253e51c", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000191266", "N0000187064", "N0000187063", "N0000185607", "N0000191267", "N0000190118", "N0000185507"], "unii": ["6158TKW0C5"], "rxcui": ["1313885"], "spl_set_id": ["e95cad66-b5f9-4802-a35f-fed340bf09ab"], "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": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, CHEWABLE in 1 BOTTLE (64980-573-01)", "package_ndc": "64980-573-01", "marketing_start_date": "20240503"}], "brand_name": "Phenytoin", "product_id": "64980-573_14ec4c18-fa7a-46e6-ac18-a7c23253e51c", "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": "64980-573", "generic_name": "Phenytoin", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenytoin", "active_ingredients": [{"name": "PHENYTOIN", "strength": "50 mg/1"}], "application_number": "ANDA200691", "marketing_category": "ANDA", "marketing_start_date": "20240503", "listing_expiration_date": "20261231"}