Phenytoin

Product NDC
66689-036
11-digit product format
666890036
Labeler code
66689
Product ID
66689-036_c24a0d96-5333-4123-b595-44136ad7bc43
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin
Dosage form
SUSPENSION
Route
ORAL
Labeler
VistaPharm, Inc.
Application
ANDA040342
Marketing category
ANDA
Marketing start
2010-05-10
Marketing end
0000-00-00
Substance
PHENYTOIN
Active strength
125 mg/5mL
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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66689-036-502024-01-30C16284748780-11030e364-fcc6-111a-e063-dadaa90a10e285cc5cd9-695f-4a71-9275-e0099c505185

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-036-01ML - Milliliter66689-03655e6e511-b376-4b6d-9876-c161285ad4c212012-07-24
66689-036-50ML - Milliliter66689-036099bc12b-07cc-470d-8e68-2718eb515a9d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PhenytoinACTIVE INGREDIENT6158TKW0C5PHENYTOIN SUSPENSION [VISTAPHARM INC.]3
PhenytoinACTIVE MOIETY6158TKW0C5PHENYTOIN SUSPENSION [VISTAPHARM INC.]3
Anhydrous Citric AcidINACTIVE INGREDIENTXF417D3PSLPHENYTOIN SUSPENSION [VISTAPHARM INC.]3
Carboxymethylcellulose SodiumINACTIVE INGREDIENTK679OBS311PHENYTOIN SUSPENSION [VISTAPHARM INC.]3
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8PHENYTOIN SUSPENSION [VISTAPHARM INC.]3
GlycerinINACTIVE INGREDIENTPDC6A3C0OXPHENYTOIN SUSPENSION [VISTAPHARM INC.]3
Magnesium Aluminum SilicateINACTIVE INGREDIENT6M3P64V0NCPHENYTOIN SUSPENSION [VISTAPHARM INC.]3
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HPHENYTOIN SUSPENSION [VISTAPHARM INC.]3
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUPHENYTOIN SUSPENSION [VISTAPHARM INC.]3
SucroseINACTIVE INGREDIENTC151H8M554PHENYTOIN SUSPENSION [VISTAPHARM INC.]3
WaterINACTIVE INGREDIENT059QF0KO0RPHENYTOIN SUSPENSION [VISTAPHARM INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66689-036PHENYTOIN SUSPENSION [VISTAPHARM, LLC]19Legacy NDC20240510_85cc5cd9-695f-4a71-9275-e0099c505185.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66689-036-50666890036505 TRAY in 1 CASE (66689-036-50) > 10 CUP, UNIT-DOSE in 1 TRAY > 4 mL in 1 CUP, UNIT-DOSE (66689-036-01) 5 tray2010-05-100000-00-00NoNoCurrent