FDA.reportPublic FDA data

Phenytoin Sodium

Product NDC
0378-1560
11-digit product format
003781560
Labeler code
0378
Product ID
0378-1560_1d448420-390f-46ad-ad5a-3145e77be8ca
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
1999-01-05
Marketing end
2023-02-28
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
0000-00-00
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-1560-01EA - Each0378-1560ba2261b3-2fdb-483a-9b17-f27c10f8fd8712012-07-24
0378-1560-10EA - Each0378-1560134b8f38-b7b8-4f66-b23f-41d22c7a970512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
PHENYTOINACTIVE MOIETY6158TKW0C5PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
GELATININACTIVE INGREDIENT2G86QN327LPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN16PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SHELLACINACTIVE INGREDIENT46N107B71OPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]2
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHPHENYTOIN ER (PHENYTOIN SODIUM) CAPSULE [STAT RX USA LLC]1
PHENYTOINACTIVE MOIETY6158TKW0C5PHENYTOIN ER (PHENYTOIN SODIUM) CAPSULE [STAT RX USA LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN404bb4d0-dade-4fb7-a85d-d5233d49fd982
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSNcc521263-7ddc-4a79-a3ca-466848e32c232
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD404bb4d0-dade-4fb7-a85d-d5233d49fd982
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCDcc521263-7ddc-4a79-a3ca-466848e32c232
855671DPH sodium 100 MG Extended Release Oral CapsuleSY404bb4d0-dade-4fb7-a85d-d5233d49fd982
855671DPH sodium 100 MG Extended Release Oral CapsuleSYcc521263-7ddc-4a79-a3ca-466848e32c232
855671phenytoin sodium 100 MG Extended Release Oral CapsulePSN9367137e-200c-48c6-9634-135e1faeb1011
855671phenytoin sodium 100 MG Extended Release Oral CapsuleSCD9367137e-200c-48c6-9634-135e1faeb1011
855671DPH sodium 100 MG Extended Release Oral CapsuleSY9367137e-200c-48c6-9634-135e1faeb1011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-1560-0100378156001100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1560-01) 1999-01-052030-01-01NoNoCurrent
0378-1560-10003781560101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1560-10) 1999-01-052030-01-01NoNoCurrent