FDA.reportPublic FDA data

Dilantin

Product NDC
43353-131
11-digit product format
433530131
Labeler code
43353
Product ID
43353-131_0bedfead-19aa-4149-ba58-4d0f189267b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, Inc.
Application
ANDA084349
Marketing category
ANDA
Marketing start
1976-08-27
Marketing end
0000-00-00
Substance
PHENYTOIN SODIUM
Active strength
100 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
No
Listing certified through
2019-12-31
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
43353-131-602020-01-31C16284748780-19d75b9d1-1b24-f424-e053-dadaa90a57ceDilantin ® (extended phenytoin sodium capsules, USP) 100 mg
43353-131-702020-01-31C16284748780-19d75b9d1-1b24-f424-e053-dadaa90a57ceDilantin ® (extended phenytoin sodium capsules, USP) 100 mg
43353-131-752020-01-31C16284748780-19d75b9d1-1b24-f424-e053-dadaa90a57ceDilantin ® (extended phenytoin sodium capsules, USP) 100 mg
43353-131-922020-01-31C16284748780-19d75b9d1-1b24-f424-e053-dadaa90a57ceDilantin ® (extended phenytoin sodium capsules, USP) 100 mg
43353-131-942020-01-31C16284748780-19d75b9d1-1b24-f424-e053-dadaa90a57ceDilantin ® (extended phenytoin sodium capsules, USP) 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-131-60Dilantin90 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE901
43353-131-70Dilantin120 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE1201
43353-131-75Dilantin150 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE1501
43353-131-92Dilantin270 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE2701
43353-131-94Dilantin360 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE3601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-131-60EA - Each43353-131592a81a7-2c35-43b3-beef-645d6dbb52b212014-08-01
43353-131-70EA - Each43353-131f822a8eb-851a-40d1-8b92-43c22358de9812013-03-03
43353-131-75EA - Each43353-131573aad27-3d74-442c-9128-ddc5e683e5f812013-03-03
43353-131-92EA - Each43353-13151a0cc1f-6241-4125-ab1c-ff2d3cc72e0c12013-03-03
43353-131-94EA - Each43353-131ca619f59-c4fa-415c-8a96-20f67d54cb7e12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Phenytoin SodiumACTIVE INGREDIENT4182431BJHDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
PhenytoinACTIVE MOIETY6158TKW0C5DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
D&C red No. 28INACTIVE INGREDIENT767IP0Y5NHDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
FD&C yellow No. 6INACTIVE INGREDIENTH77VEI93A8DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
gelatinINACTIVE INGREDIENT2G86QN327LDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
sucroseINACTIVE INGREDIENTC151H8M554DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
talcINACTIVE INGREDIENT7SEV7J4R1UDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-131DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1Legacy NDC, 5 package rows20120815_ecab970d-83e9-4aad-92de-dbb73d7a151f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855673Dilantin 100 MG Extended Release Oral CapsulePSNecab970d-83e9-4aad-92de-dbb73d7a151f1
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSNecab970d-83e9-4aad-92de-dbb73d7a151f1
855673phenytoin sodium 100 MG Extended Release Oral Capsule [Dilantin]SBDecab970d-83e9-4aad-92de-dbb73d7a151f1
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCDecab970d-83e9-4aad-92de-dbb73d7a151f1
855673Dilantin 100 MG Extended Release Oral CapsuleSYecab970d-83e9-4aad-92de-dbb73d7a151f1
855671DPH sodium 100 MG Extended Release Oral CapsuleSYecab970d-83e9-4aad-92de-dbb73d7a151f1
855673DPH sodium 100 MG Extended Release Oral Capsule [Dilantin]SYecab970d-83e9-4aad-92de-dbb73d7a151f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-131-604335301316090 in 1 BOTTLE, PLASTICHistorical
43353-131-7043353013170120 in 1 BOTTLE, PLASTICHistorical
43353-131-7543353013175150 in 1 BOTTLE, PLASTICHistorical
43353-131-9243353013192270 in 1 BOTTLE, PLASTICHistorical
43353-131-9443353013194360 in 1 BOTTLE, PLASTICHistorical