FDA.reportPublic FDA data

Phenytek

Product NDC
0378-3750
11-digit product format
003783750
Labeler code
0378
Product ID
0378-3750_a532ea94-0186-4554-969c-66ff80f95c94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
phenytoin sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA040298
Marketing category
ANDA
Marketing start
2001-12-10
Substance
PHENYTOIN SODIUM
Active strength
300 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
Phenytek
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYTOIN SODIUM300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4182431BJH
Rxcui855861, 855863, 855873, 855875

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
e3d31abf-5149-4e77-89a8-0dc73ec106f9Product name120210525
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecbProduct name220200303
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
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
0378-3750-01Phenytek100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10021
0378-3750-93Phenytek30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-3750-01EA - Each0378-3750d4822c25-d0f2-4146-82fc-7819a2735bfb12012-07-24
0378-3750-93EA - Each0378-375091c265a7-9190-4ef0-bc4e-0b2a300a516f12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHPHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
PHENYTOINACTIVE MOIETY6158TKW0C5PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
GELATININACTIVE INGREDIENT2G86QN327LPHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN16PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GPHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
POVIDONESINACTIVE INGREDIENTFZ989GH94EPHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
SHELLACINACTIVE INGREDIENT46N107B71OPHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-3750PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE PHENYTEK (PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]21Current NDC, Legacy NDC, 2 package rows20241113_0f94c791-8b07-4b41-927e-c9f28bec5f60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855863Phenytek 200 MG Extended Release Oral CapsulePSN0f94c791-8b07-4b41-927e-c9f28bec5f6021
855875Phenytek 300 MG Extended Release Oral CapsulePSN0f94c791-8b07-4b41-927e-c9f28bec5f6021
855861phenytoin sodium 200 MG Extended Release Oral CapsulePSN0f94c791-8b07-4b41-927e-c9f28bec5f6021
855873phenytoin sodium 300 MG Extended Release Oral CapsulePSN0f94c791-8b07-4b41-927e-c9f28bec5f6021
855863phenytoin sodium 200 MG Extended Release Oral Capsule [Phenytek]SBD0f94c791-8b07-4b41-927e-c9f28bec5f6021
855875phenytoin sodium 300 MG Extended Release Oral Capsule [Phenytek]SBD0f94c791-8b07-4b41-927e-c9f28bec5f6021
855861phenytoin sodium 200 MG Extended Release Oral CapsuleSCD0f94c791-8b07-4b41-927e-c9f28bec5f6021
855873phenytoin sodium 300 MG Extended Release Oral CapsuleSCD0f94c791-8b07-4b41-927e-c9f28bec5f6021
855861DPH sodium 200 MG Extended Release Oral CapsuleSY0f94c791-8b07-4b41-927e-c9f28bec5f6021
855863DPH sodium 200 MG Extended Release Oral Capsule [Phenytek]SY0f94c791-8b07-4b41-927e-c9f28bec5f6021
855873DPH sodium 300 MG Extended Release Oral CapsuleSY0f94c791-8b07-4b41-927e-c9f28bec5f6021
855875DPH sodium 300 MG Extended Release Oral Capsule [Phenytek]SY0f94c791-8b07-4b41-927e-c9f28bec5f6021
855863Phenytek 200 MG Extended Release Oral CapsuleSY0f94c791-8b07-4b41-927e-c9f28bec5f6021
855875Phenytek 300 MG Extended Release Oral CapsuleSY0f94c791-8b07-4b41-927e-c9f28bec5f6021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-3750-0100378375001100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-3750-01) 2001-12-102030-01-31NoNoCurrent
0378-3750-930037837509330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0378-3750-93) 2001-12-102030-01-31NoNoCurrent