FDA.reportPublic FDA data

Extended Phenytoin Sodium

Product NDC
65162-212
11-digit product format
651620212
Labeler code
65162
Product ID
65162-212_ba4af35a-0bb4-4c62-bf75-174b2b5a5aba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin Sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA040765
Marketing category
ANDA
Marketing start
2009-12-16
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Extended Phenytoin Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYTOIN SODIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4182431BJH

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-212-03Extended Phenytoin Sodium30 in 1 BOTTLECAPSULE3027
65162-212-10Extended Phenytoin Sodium100 in 1 BOTTLECAPSULE10027
65162-212-11Extended Phenytoin Sodium1000 in 1 BOTTLECAPSULE100027
65162-212-50Extended Phenytoin Sodium500 in 1 BOTTLECAPSULE50027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-212-10EA - Each65162-212997d2ccb-f46e-4f16-b268-946e6c6c9fab12012-07-24
65162-212-11EA - Each65162-212e2c3ef5e-7476-437f-8920-eff23b20d75512012-07-24
65162-212-50EA - Each65162-212b0c46b0b-74bc-4a0d-bad6-85174a697bf712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
PHENYTOINACTIVE MOIETY6158TKW0C5EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]13
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
PHENYTOINACTIVE MOIETY6158TKW0C5EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
GELATININACTIVE INGREDIENT2G86QN327LEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
MANNITOLINACTIVE INGREDIENT3OWL53L36AEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]8
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHEXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHPHENYTOIN SODIUM CAPSULE [DIRECT RX]1
PHENYTOINACTIVE MOIETY6158TKW0C5EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PHENYTOINACTIVE MOIETY6158TKW0C5PHENYTOIN SODIUM CAPSULE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-212EXTENDED PHENYTOIN SODIUM (PHENYTOIN SODIUM) CAPSULE [AMNEAL PHARMACEUTICALS LLC]26Current NDC, Legacy NDC, 4 package rows20241027_7e467c02-49a0-4b62-b537-430fdfa4f10e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSNdf0bf42b-ce9a-42c3-8c24-46f1ea3bd2144
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCDdf0bf42b-ce9a-42c3-8c24-46f1ea3bd2144
855671DPH sodium 100 MG Extended Release Oral CapsuleSYdf0bf42b-ce9a-42c3-8c24-46f1ea3bd2144
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN295acc10-5c96-437c-946f-112f7e6a09c81
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD295acc10-5c96-437c-946f-112f7e6a09c81
855671DPH sodium 100 MG Extended Release Oral CapsuleSY295acc10-5c96-437c-946f-112f7e6a09c81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-212-036516202120330 CAPSULE in 1 BOTTLE (65162-212-03) 30 capsule2009-12-160000-00-00NoNoCurrent
65162-212-1065162021210100 CAPSULE in 1 BOTTLE (65162-212-10) 100 capsule2009-12-160000-00-00NoNoCurrent
65162-212-11651620212111000 CAPSULE in 1 BOTTLE (65162-212-11) 1000 capsule2009-12-160000-00-00NoNoCurrent
65162-212-5065162021250500 CAPSULE in 1 BOTTLE (65162-212-50) 500 capsule2009-12-160000-00-00NoNoCurrent