FDA.reportPublic FDA data

Phenytoin

Product NDC
60687-275
11-digit product format
606870275
Labeler code
60687
Product ID
60687-275_3f00559d-7f12-eadc-e063-6294a90a7962
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin
Dosage form
SUSPENSION
Route
ORAL
Labeler
American Health Packaging
Application
ANDA040521
Marketing category
ANDA
Marketing start
2019-01-10
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
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
60687-275-62Phenytoin4 mL in 1 CUP, UNIT-DOSESUSPENSION46
60687-275-63Phenytoin10 in 1 TRAYSUSPENSION106
60687-275-66Phenytoin5 in 1 CASESUSPENSION56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-275-62ML - Milliliter60687-2759eeb7fc2-c459-45dd-aa93-4993e16e07d212019-01-24
60687-275-63ML - Milliliter60687-2757d468578-d456-4e00-8208-bb8ce8f4946812019-02-13
60687-275-66ML - Milliliter60687-2757283124c-8cd0-4aa7-bbd3-fe848f854d4812019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-275PHENYTOIN SUSPENSION [AMERICAN HEALTH PACKAGING]5Current NDC, Legacy NDC, 3 package rows20221101_f9fe4c92-2761-4cb4-9cf3-7066e240e014.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-275-62606870275624 mL in 1 CUP, UNIT-DOSE4 mlHistorical
60687-275-636068702756310 in 1 TRAYHistorical
60687-275-66606870275665 TRAY in 1 CASE (60687-275-66) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-275-63) / 4 mL in 1 CUP, UNIT-DOSE (60687-275-62) 5 tray2019-01-100000-00-00NoNoCurrent