FDA.reportPublic FDA data

Dilantin

Product NDC
68151-1019
11-digit product format
681511019
Labeler code
68151
Product ID
68151-1019_c536d481-cc6d-4d3e-8d1d-accbec36c4dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA084349
Marketing category
ANDA
Marketing start
1976-08-27
Marketing end
0000-00-00
Substance
PHENYTOIN SODIUM
Active strength
30 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],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]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-1019-62020-01-31C16284748780-19d75b9d1-0ed0-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use DILANTIN ® safely and effectively. See full prescribing information for DILANTIN ® . DILANTIN ® (phenytoin sodium) Extended Capsules, for oral use Initial U.S. Approval: 1953

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-1019-6Dilantin1 in 1 PACKAGECAPSULE, EXTENDED RELEASE14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
PHENYTOINACTIVE MOIETY6158TKW0C5DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
GELATININACTIVE INGREDIENT2G86QN327LDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
SUCROSEINACTIVE INGREDIENTC151H8M554DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
TALCINACTIVE INGREDIENT7SEV7J4R1UDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-1019DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]4Legacy NDC, 1 package rows20170706_4f918d15-908e-4c3a-94d6-71370da9a116.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855871Dilantin 30 MG Extended Release Oral CapsulePSN4f918d15-908e-4c3a-94d6-71370da9a1164
855869phenytoin sodium 30 MG Extended Release Oral CapsulePSN4f918d15-908e-4c3a-94d6-71370da9a1164
855871phenytoin sodium 30 MG Extended Release Oral Capsule [Dilantin]SBD4f918d15-908e-4c3a-94d6-71370da9a1164
855869phenytoin sodium 30 MG Extended Release Oral CapsuleSCD4f918d15-908e-4c3a-94d6-71370da9a1164
855871Dilantin 30 MG Extended Release Oral CapsuleSY4f918d15-908e-4c3a-94d6-71370da9a1164
855869DPH sodium 30 MG Extended Release Oral CapsuleSY4f918d15-908e-4c3a-94d6-71370da9a1164
855871DPH sodium 30 MG Extended Release Oral Capsule [Dilantin]SY4f918d15-908e-4c3a-94d6-71370da9a1164

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-1019-6681511019061 in 1 PACKAGEHistorical