FDA.reportPublic FDA data

Dilantin-125

Product NDC
58151-115
11-digit product format
581510115
Labeler code
58151
Product ID
58151-115_f339f9e4-b289-4efe-82b9-46c57d1dc277
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Viatris Specialty LLC
Application
NDA008762
Marketing category
NDA
Marketing start
2024-04-19
Substance
PHENYTOIN
Active strength
125 mg/5mL
Pharmacologic classes
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]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dilantin-125
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYTOIN125 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6158TKW0C5
Rxcui1313112, 1313884

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
e3d31abf-5149-4e77-89a8-0dc73ec106f9Product name120210525
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecbProduct name220200303
031bbc61-0564-1f35-2716-aa5c1d139248Product name220141218
cc830ceb-037c-a5c3-ee14-3d82c0e89e70Product name120140508
eafc3fd3-6834-3129-5bbb-8a9a495691abProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58151-115-35Dilantin-125237 mL in 1 BOTTLE, PLASTICSUSPENSION2371
58151-115-35Dilantin-1251 in 1 CARTONSUSPENSION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-115DILANTIN-125 (PHENYTOIN) SUSPENSION [VIATRIS SPECIALTY LLC]1Current NDC, 2 package rows20240420_f339f9e4-b289-4efe-82b9-46c57d1dc277.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1313884Dilantin-125, 125 MG in 5 mL Oral SuspensionPSNf339f9e4-b289-4efe-82b9-46c57d1dc2771
1313112phenytoin 125 MG in 5 mL Oral SuspensionPSNf339f9e4-b289-4efe-82b9-46c57d1dc2771
1313884phenytoin 25 MG/ML Oral Suspension [Dilantin]SBDf339f9e4-b289-4efe-82b9-46c57d1dc2771
1313112phenytoin 25 MG/ML Oral SuspensionSCDf339f9e4-b289-4efe-82b9-46c57d1dc2771
1313884Dilantin 125 MG per 5 ML Oral SuspensionSYf339f9e4-b289-4efe-82b9-46c57d1dc2771
1313884Dilantin 25 MG/ML Oral SuspensionSYf339f9e4-b289-4efe-82b9-46c57d1dc2771
1313884Dilantin-125 Oral SuspensionSYf339f9e4-b289-4efe-82b9-46c57d1dc2771
1313112DPH 25 MG/ML Oral SuspensionSYf339f9e4-b289-4efe-82b9-46c57d1dc2771
1313884DPH 25 MG/ML Oral Suspension [Dilantin]SYf339f9e4-b289-4efe-82b9-46c57d1dc2771
1313112phenytoin 100 MG per 4 ML Oral SuspensionSYf339f9e4-b289-4efe-82b9-46c57d1dc2771
1313112phenytoin 125 MG per 5 ML Oral SuspensionSYf339f9e4-b289-4efe-82b9-46c57d1dc2771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
58151-115-35581510115351 BOTTLE, PLASTIC in 1 CARTON (58151-115-35) / 237 mL in 1 BOTTLE, PLASTIC2024-04-19NoNoCurrent