FDA.reportPublic FDA data

Dilantin

Product NDC
50090-0029
11-digit product format
500900029
Labeler code
50090
Product ID
50090-0029_8657e0f0-e112-44ad-a896-c3ce1b884012
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
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
2020-12-31
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
50090-0029-22021-01-29C16284748780-1ba0f9c33-2617-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use DILANTIN ® safely and effectively. See full prescribing information for DILANTIN ® . DILANTIN ® (extended phenytoin sodium capsules), for oral use Initial U.S. Approval: 1953

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0029-2Dilantin30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0029-2EA - Each50090-00295ebc07d0-450c-4ebf-b649-0acda2ba408a12018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
PHENYTOINACTIVE MOIETY6158TKW0C5DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0029DILANTIN (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]11Legacy NDC, 1 package rows20190402_f5b7e576-49b1-4633-ab0a-6ab94922e970.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855673Dilantin 100 MG Extended Release Oral CapsulePSNf5b7e576-49b1-4633-ab0a-6ab94922e97011
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSNf5b7e576-49b1-4633-ab0a-6ab94922e97011
855673phenytoin sodium 100 MG Extended Release Oral Capsule [Dilantin]SBDf5b7e576-49b1-4633-ab0a-6ab94922e97011
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCDf5b7e576-49b1-4633-ab0a-6ab94922e97011
855673Dilantin 100 MG Extended Release Oral CapsuleSYf5b7e576-49b1-4633-ab0a-6ab94922e97011
855671DPH sodium 100 MG Extended Release Oral CapsuleSYf5b7e576-49b1-4633-ab0a-6ab94922e97011
855673DPH sodium 100 MG Extended Release Oral Capsule [Dilantin]SYf5b7e576-49b1-4633-ab0a-6ab94922e97011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-0029-25009000290230 in 1 BOTTLEHistorical