FDA.reportPublic FDA data

Phenytoin

Product NDC
59762-0531
11-digit product format
597620531
Labeler code
59762
Product ID
59762-0531_212141a3-fffd-49e0-96d5-57cc921a99d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA008762
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-04-22
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phenytoin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYTOIN125 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6158TKW0C5
Rxcui1313112

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
e3d31abf-5149-4e77-89a8-0dc73ec106f9Product name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
b251e19b-cfda-4a5c-8c9c-f4dad5d55ecbProduct name220200303
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
59762-0531-2Phenytoin1 in 1 CARTONSUSPENSION131
59762-0531-2Phenytoin237 mL in 1 BOTTLE, PLASTICSUSPENSION23731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0531-1ML - Milliliter59762-05316bc19a70-2c0d-437c-9ca1-28dd3d03b6e612013-02-13
59762-0531-2ML - Milliliter59762-0531d79c9764-a7ae-4f3d-923b-76e8b8cf367812020-07-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYTOINACTIVE INGREDIENT6158TKW0C5PHENYTOIN SUSPENSION [GREENSTONE LLC]8
PHENYTOINACTIVE MOIETY6158TKW0C5PHENYTOIN SUSPENSION [GREENSTONE LLC]8
ALCOHOLINACTIVE INGREDIENT3K9958V90MPHENYTOIN SUSPENSION [GREENSTONE LLC]8
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLPHENYTOIN SUSPENSION [GREENSTONE LLC]8
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMINACTIVE INGREDIENTK679OBS311PHENYTOIN SUSPENSION [GREENSTONE LLC]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PHENYTOIN SUSPENSION [GREENSTONE LLC]8
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPHENYTOIN SUSPENSION [GREENSTONE LLC]8
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCPHENYTOIN SUSPENSION [GREENSTONE LLC]8
POLYSORBATE 40INACTIVE INGREDIENTSTI11B5A2XPHENYTOIN SUSPENSION [GREENSTONE LLC]8
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUPHENYTOIN SUSPENSION [GREENSTONE LLC]8
SUCROSEINACTIVE INGREDIENTC151H8M554PHENYTOIN SUSPENSION [GREENSTONE LLC]8
VANILLININACTIVE INGREDIENTCHI530446XPHENYTOIN SUSPENSION [GREENSTONE LLC]8
WATERINACTIVE INGREDIENT059QF0KO0RPHENYTOIN SUSPENSION [GREENSTONE LLC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0531PHENYTOIN SUSPENSION [MYLAN PHARMACEUTICALS INC.]31Current NDC, Legacy NDC, 2 package rows20250503_37943ec1-a8d2-42df-967e-6f96f84c017b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1313112phenytoin 125 MG in 5 mL Oral SuspensionPSN37943ec1-a8d2-42df-967e-6f96f84c017b31
1313112phenytoin 25 MG/ML Oral SuspensionSCD37943ec1-a8d2-42df-967e-6f96f84c017b31
1313112DPH 25 MG/ML Oral SuspensionSY37943ec1-a8d2-42df-967e-6f96f84c017b31
1313112phenytoin 100 MG per 4 ML Oral SuspensionSY37943ec1-a8d2-42df-967e-6f96f84c017b31
1313112phenytoin 125 MG per 5 ML Oral SuspensionSY37943ec1-a8d2-42df-967e-6f96f84c017b31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-0531-2597620531021 BOTTLE, PLASTIC in 1 CARTON (59762-0531-2) / 237 mL in 1 BOTTLE, PLASTIC2020-04-220000-00-00NoNoCurrent