FDA.reportPublic FDA data

PHENYTOIN SODIUM

Product NDC
62756-402
11-digit product format
627560402
Labeler code
62756
Product ID
62756-402_9f1bb601-e3fa-4c9a-9021-5a6a0a9b60c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PHENYTOIN SODIUM
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA040621
Marketing category
ANDA
Marketing start
2006-12-12
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
62756-402-012020-01-31C16284748780-19d75b9d0-6460-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
62756-402-022020-01-31C16284748780-19d75b9d0-6460-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953
62756-402-032020-01-31C16284748780-19d75b9d0-6460-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use EXTENDED PHENYTOIN SODIUM CAPSULES safely and effectively. See full prescribing information for EXTENDED PHENYTOIN SODIUM CAPSULES. EXTENDED PHENYTOIN SODIUM capsules, for oral use Initial U.S. Approval: 1953

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62756-402-01PHENYTOIN SODIUM100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10010
62756-402-02PHENYTOIN SODIUM100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10010
62756-402-03PHENYTOIN SODIUM1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62756-402-01EA - Each62756-4020c62cb04-72e4-4e7f-b1c8-a88e9dc6747d12012-07-24
62756-402-03EA - Each62756-402913103cf-391f-41ca-bd56-250bf0e0ddee12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
PHENYTOINACTIVE MOIETY6158TKW0C5PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
GELATININACTIVE INGREDIENT2G86QN327LPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
LACTITOL MONOHYDRATEINACTIVE INGREDIENTUH2K6W1Y64PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
SHELLACINACTIVE INGREDIENT46N107B71OPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6
TALCINACTIVE INGREDIENT7SEV7J4R1UPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES LIMITED ]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-402PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]10Legacy NDC, 3 package rows20181024_422408c1-ca13-4743-9773-9641eca28f18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN422408c1-ca13-4743-9773-9641eca28f1810
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD422408c1-ca13-4743-9773-9641eca28f1810
855671DPH sodium 100 MG Extended Release Oral CapsuleSY422408c1-ca13-4743-9773-9641eca28f1810
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN7f20cf98-1a63-4eaf-a7ac-fa5d79a045e05
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD7f20cf98-1a63-4eaf-a7ac-fa5d79a045e05
855671DPH sodium 100 MG Extended Release Oral CapsuleSY7f20cf98-1a63-4eaf-a7ac-fa5d79a045e05
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN5268708d-770f-0a29-e054-00144ff88e882
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD5268708d-770f-0a29-e054-00144ff88e882
855671DPH sodium 100 MG Extended Release Oral CapsuleSY5268708d-770f-0a29-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
62756-402-0162756040201100 in 1 BOTTLEHistorical
62756-402-0262756040202100 in 1 BOTTLEHistorical
62756-402-03627560402031000 in 1 BOTTLEHistorical