dilantin-125

Generic: phenytoin

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name dilantin-125
Generic Name phenytoin
Labeler viatris specialty llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

phenytoin 125 mg/5mL

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 58151-115
Product ID 58151-115_f339f9e4-b289-4efe-82b9-46c57d1dc277
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA008762
Listing Expiration 2026-12-31
Marketing Start 2024-04-19

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 58151115
Hyphenated Format 58151-115

Supplemental Identifiers

RxCUI
1313112 1313884
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-125 (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 (58151-115-35) / 237 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

58151-115-35 1 BOTTLE, PLASTIC in 1 CARTON (58151-115-35) / 237 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

phenytoin (125 mg/5mL)

Linked Drug Pages (1)

Dilantin-125 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f339f9e4-b289-4efe-82b9-46c57d1dc277", "openfda": {"nui": ["N0000175753", "N0000008486", "N0000191266", "N0000187064", "N0000187063", "N0000185607", "N0000191267", "N0000190118", "N0000185507"], "unii": ["6158TKW0C5"], "rxcui": ["1313112", "1313884"], "spl_set_id": ["f339f9e4-b289-4efe-82b9-46c57d1dc277"], "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": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (58151-115-35)  / 237 mL in 1 BOTTLE, PLASTIC", "package_ndc": "58151-115-35", "marketing_start_date": "20240419"}], "brand_name": "Dilantin-125", "product_id": "58151-115_f339f9e4-b289-4efe-82b9-46c57d1dc277", "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": "58151-115", "generic_name": "Phenytoin", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dilantin-125", "active_ingredients": [{"name": "PHENYTOIN", "strength": "125 mg/5mL"}], "application_number": "NDA008762", "marketing_category": "NDA", "marketing_start_date": "20240419", "listing_expiration_date": "20261231"}