FDA.reportPublic FDA data

Phenytoin

Product NDC
51672-4069
11-digit product format
516724069
Labeler code
51672
Product ID
51672-4069_3cbd8a0c-6cfb-e0dd-e063-6394a90a8a26
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA040521
Marketing category
ANDA
Marketing start
2004-04-08
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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
51672-4069-1Phenytoin237 mL in 1 BOTTLESUSPENSION23717
51672-4069-2Phenytoin237 mL in 1 BOTTLESUSPENSION23717
51672-4069-2Phenytoin1 in 1 CARTONSUSPENSION117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4069-1ML - Milliliter51672-4069ad64fdf1-fd54-465f-ac07-356560e8268f12012-07-24
51672-4069-2ML - Milliliter51672-4069bce3d4d5-d92a-43ce-83b8-eaf43c3eb96912025-08-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PhenytoinACTIVE INGREDIENT6158TKW0C5PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]6
PhenytoinACTIVE MOIETY6158TKW0C5PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]6
anhydrous citric acidINACTIVE INGREDIENTXF417D3PSLPHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]6
carboxymethylcellulose sodiumINACTIVE INGREDIENTK679OBS311PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]6
FD&C yellow no. 6INACTIVE INGREDIENTH77VEI93A8PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]6
magnesium aluminum silicateINACTIVE INGREDIENT6M3P64V0NCPHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]6
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MPHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]6
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUPHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]6
sucroseINACTIVE INGREDIENTC151H8M554PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]6
waterINACTIVE INGREDIENT059QF0KO0RPHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4069PHENYTOIN SUSPENSION [TARO PHARMACEUTICALS U.S.A., INC.]14Current NDC, Legacy NDC, 3 package rows20220429_093fd736-5971-47af-b4ef-08c1696cebe8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1313112phenytoin 125 MG in 5 mL Oral SuspensionPSN093fd736-5971-47af-b4ef-08c1696cebe817
1313112phenytoin 25 MG/ML Oral SuspensionSCD093fd736-5971-47af-b4ef-08c1696cebe817
1313112DPH 25 MG/ML Oral SuspensionSY093fd736-5971-47af-b4ef-08c1696cebe817
1313112phenytoin 100 MG per 4 ML Oral SuspensionSY093fd736-5971-47af-b4ef-08c1696cebe817
1313112phenytoin 125 MG per 5 ML Oral SuspensionSY093fd736-5971-47af-b4ef-08c1696cebe817
1313112phenytoin 125 MG in 5 mL Oral SuspensionPSNf9fe4c92-2761-4cb4-9cf3-7066e240e0146
1313112phenytoin 25 MG/ML Oral SuspensionSCDf9fe4c92-2761-4cb4-9cf3-7066e240e0146
1313112DPH 25 MG/ML Oral SuspensionSYf9fe4c92-2761-4cb4-9cf3-7066e240e0146
1313112phenytoin 100 MG per 4 ML Oral SuspensionSYf9fe4c92-2761-4cb4-9cf3-7066e240e0146
1313112phenytoin 125 MG per 5 ML Oral SuspensionSYf9fe4c92-2761-4cb4-9cf3-7066e240e0146
1313112phenytoin 125 MG in 5 mL Oral SuspensionPSN09daf485-3355-44cb-92af-072dd281e1295
1313112phenytoin 25 MG/ML Oral SuspensionSCD09daf485-3355-44cb-92af-072dd281e1295
1313112DPH 25 MG/ML Oral SuspensionSY09daf485-3355-44cb-92af-072dd281e1295
1313112phenytoin 100 MG per 4 ML Oral SuspensionSY09daf485-3355-44cb-92af-072dd281e1295
1313112phenytoin 125 MG per 5 ML Oral SuspensionSY09daf485-3355-44cb-92af-072dd281e1295
1313112phenytoin 125 MG in 5 mL Oral SuspensionPSNf2c74e35-ed8d-4ea6-b7a5-7be0b0155c154
1313112phenytoin 25 MG/ML Oral SuspensionSCDf2c74e35-ed8d-4ea6-b7a5-7be0b0155c154
1313112DPH 25 MG/ML Oral SuspensionSYf2c74e35-ed8d-4ea6-b7a5-7be0b0155c154
1313112phenytoin 100 MG per 4 ML Oral SuspensionSYf2c74e35-ed8d-4ea6-b7a5-7be0b0155c154
1313112phenytoin 125 MG per 5 ML Oral SuspensionSYf2c74e35-ed8d-4ea6-b7a5-7be0b0155c154

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4069-151672406901237 mL in 1 BOTTLE (51672-4069-1) 237 ml2004-04-082026-07-31NoNoCurrent
51672-4069-2516724069021 BOTTLE in 1 CARTON (51672-4069-2) / 237 mL in 1 BOTTLE1 bottle2025-07-23NoNoHistorical