FDA.reportPublic FDA data

DILANTIN

Product NDC
58151-118
11-digit product format
581510118
Labeler code
58151
Product ID
58151-118_872f23a8-e6a3-4038-922d-0c26fc81d8b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Extended Phenytoin Sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Viatris Specialty LLC
Application
ANDA084349
Marketing category
ANDA
Marketing start
2025-01-15
Substance
PHENYTOIN SODIUM
Active strength
30 mg/1
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYTOIN SODIUM30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4182431BJH
Rxcui855671, 855673, 855869, 855871

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
58151-118-01DILANTIN100 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-118-01EA - Each58151-11806c05582-25ba-450c-a92a-d8c029ac28f512025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-118DILANTIN (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [VIATRIS SPECIALTY LLC]3Current NDC, 1 package rows20250410_86dd27d1-9cee-48ae-b55d-e2d2f7dbc593.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855673Dilantin 100 MG Extended Release Oral CapsulePSN86dd27d1-9cee-48ae-b55d-e2d2f7dbc5933
855871Dilantin 30 MG Extended Release Oral CapsulePSN86dd27d1-9cee-48ae-b55d-e2d2f7dbc5933
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN86dd27d1-9cee-48ae-b55d-e2d2f7dbc5933
855869phenytoin sodium 30 MG Extended Release Oral CapsulePSN86dd27d1-9cee-48ae-b55d-e2d2f7dbc5933
855673phenytoin sodium 100 MG Extended Release Oral Capsule [Dilantin]SBD86dd27d1-9cee-48ae-b55d-e2d2f7dbc5933
855871phenytoin sodium 30 MG Extended Release Oral Capsule [Dilantin]SBD86dd27d1-9cee-48ae-b55d-e2d2f7dbc5933
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD86dd27d1-9cee-48ae-b55d-e2d2f7dbc5933
855869phenytoin sodium 30 MG Extended Release Oral CapsuleSCD86dd27d1-9cee-48ae-b55d-e2d2f7dbc5933
855673Dilantin 100 MG Extended Release Oral CapsuleSY86dd27d1-9cee-48ae-b55d-e2d2f7dbc5933
855871Dilantin 30 MG Extended Release Oral CapsuleSY86dd27d1-9cee-48ae-b55d-e2d2f7dbc5933
855671DPH sodium 100 MG Extended Release Oral CapsuleSY86dd27d1-9cee-48ae-b55d-e2d2f7dbc5933
855673DPH sodium 100 MG Extended Release Oral Capsule [Dilantin]SY86dd27d1-9cee-48ae-b55d-e2d2f7dbc5933
855869DPH sodium 30 MG Extended Release Oral CapsuleSY86dd27d1-9cee-48ae-b55d-e2d2f7dbc5933
855871DPH sodium 30 MG Extended Release Oral Capsule [Dilantin]SY86dd27d1-9cee-48ae-b55d-e2d2f7dbc5933
855871Dilantin 30 MG Extended Release Oral CapsulePSNdb8c69b0-4697-433e-98c7-b0b2d2c52a832
855869phenytoin sodium 30 MG Extended Release Oral CapsulePSNdb8c69b0-4697-433e-98c7-b0b2d2c52a832
855871phenytoin sodium 30 MG Extended Release Oral Capsule [Dilantin]SBDdb8c69b0-4697-433e-98c7-b0b2d2c52a832
855869phenytoin sodium 30 MG Extended Release Oral CapsuleSCDdb8c69b0-4697-433e-98c7-b0b2d2c52a832
855871Dilantin 30 MG Extended Release Oral CapsuleSYdb8c69b0-4697-433e-98c7-b0b2d2c52a832
855869DPH sodium 30 MG Extended Release Oral CapsuleSYdb8c69b0-4697-433e-98c7-b0b2d2c52a832
855871DPH sodium 30 MG Extended Release Oral Capsule [Dilantin]SYdb8c69b0-4697-433e-98c7-b0b2d2c52a832

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
58151-118-0158151011801100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (58151-118-01) 2025-01-15NoNoCurrent