phenytoin

Generic: phenytoin

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name phenytoin
Generic Name phenytoin
Labeler mylan pharmaceuticals inc.
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

phenytoin 125 mg/5mL

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59762-0531
Product ID 59762-0531_212141a3-fffd-49e0-96d5-57cc921a99d1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA008762
Listing Expiration 2026-12-31
Marketing Start 2020-04-22

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 597620531
Hyphenated Format 59762-0531

Supplemental Identifiers

RxCUI
1313112
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 NDA008762 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (59762-0531-2) / 237 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

59762-0531-2 1 BOTTLE, PLASTIC in 1 CARTON (59762-0531-2) / 237 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

phenytoin (125 mg/5mL)

Linked Drug Pages (1)

Phenytoin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "212141a3-fffd-49e0-96d5-57cc921a99d1", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000191266", "N0000187064", "N0000187063", "N0000185607", "N0000191267", "N0000190118", "N0000185507"], "unii": ["6158TKW0C5"], "rxcui": ["1313112"], "spl_set_id": ["37943ec1-a8d2-42df-967e-6f96f84c017b"], "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": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (59762-0531-2)  / 237 mL in 1 BOTTLE, PLASTIC", "package_ndc": "59762-0531-2", "marketing_start_date": "20200422"}], "brand_name": "Phenytoin", "product_id": "59762-0531_212141a3-fffd-49e0-96d5-57cc921a99d1", "dosage_form": "SUSPENSION", "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": "59762-0531", "generic_name": "Phenytoin", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Phenytoin", "active_ingredients": [{"name": "PHENYTOIN", "strength": "125 mg/5mL"}], "application_number": "NDA008762", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20200422", "listing_expiration_date": "20261231"}