FDA.reportPublic FDA data

Phenytek

Product NDC
67046-1486
11-digit product format
670461486
Labeler code
67046
Product ID
67046-1486_2cdc1905-8ef2-1275-e063-6394a90a2ab7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
extended phenytoin sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Coupler LLC
Application
ANDA040298
Marketing category
ANDA
Marketing start
2025-01-29
Substance
PHENYTOIN SODIUM
Active strength
200 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 SODIUM200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4182431BJH
Rxcui855861, 855863

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
67046-1486-3Phenytek30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-1486PHENYTEK (EXTENDED PHENYTOIN SODIUM) CAPSULE, EXTENDED RELEASE [COUPLER LLC]1Current NDC, 1 package rows20250130_2cdc1905-8f45-1275-e063-6394a90a2ab7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855863Phenytek 200 MG Extended Release Oral CapsulePSN2cdc1905-8f45-1275-e063-6394a90a2ab71
855861phenytoin sodium 200 MG Extended Release Oral CapsulePSN2cdc1905-8f45-1275-e063-6394a90a2ab71
855863phenytoin sodium 200 MG Extended Release Oral Capsule [Phenytek]SBD2cdc1905-8f45-1275-e063-6394a90a2ab71
855861phenytoin sodium 200 MG Extended Release Oral CapsuleSCD2cdc1905-8f45-1275-e063-6394a90a2ab71
855861DPH sodium 200 MG Extended Release Oral CapsuleSY2cdc1905-8f45-1275-e063-6394a90a2ab71
855863DPH sodium 200 MG Extended Release Oral Capsule [Phenytek]SY2cdc1905-8f45-1275-e063-6394a90a2ab71
855863Phenytek 200 MG Extended Release Oral CapsuleSY2cdc1905-8f45-1275-e063-6394a90a2ab71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
67046-1486-36704614860330 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (67046-1486-3) 2025-01-29NoNoCurrent