FDA.reportPublic FDA data

Phenytoin Sodium

Product NDC
72162-1646
11-digit product format
721621646
Labeler code
72162
Product ID
72162-1646_8c90564e-d0a0-4c02-889e-954dfea3eefd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040684
Marketing category
ANDA
Marketing start
2017-07-24
Substance
PHENYTOIN SODIUM
Active strength
100 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
Phenytoin Sodium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYTOIN SODIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4182431BJH
Rxcui855671

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1646-0Phenytoin Sodium1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE1000102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1646-0EA - Each72162-16460b1c2678-dd6a-45b2-8f89-8cd81771dfd712024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1646PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]102Current NDC, 1 package rows20241122_6b4c2885-eae0-4c88-ada3-62a699df1dbb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN6b4c2885-eae0-4c88-ada3-62a699df1dbb102
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD6b4c2885-eae0-4c88-ada3-62a699df1dbb102
855671DPH sodium 100 MG Extended Release Oral CapsuleSY6b4c2885-eae0-4c88-ada3-62a699df1dbb102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1646-0721621646001000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1646-0) 2017-07-24NoNoHistorical