FDA.reportPublic FDA data

Phenytoin

Product NDC
0121-0892
11-digit product format
001210892
Labeler code
0121
Product ID
0121-0892_4daa397f-237b-4327-91bd-d86b19e4b9b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin
Dosage form
SUSPENSION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
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
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
0121-0892-63Phenytoin4 mL in 1 CUP, UNIT-DOSESUSPENSION44

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0892-50ML - Milliliter0121-0892edee8b8b-d8c6-4963-b696-06d190b6a33b12020-07-13
0121-0892-63ML - Milliliter0121-0892c9a68b6f-c6df-4270-a09d-afb46a73cf6112020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0892PHENYTOIN SUSPENSION [PAI HOLDINGS, LLC DBA PAI PHARMA]4Current NDC, Legacy NDC, 1 package rows20241121_f2c74e35-ed8d-4ea6-b7a5-7be0b0155c15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
0121-0892-50001210892505 TRAY in 1 CASE (0121-0892-50) > 10 CUP, UNIT-DOSE in 1 TRAY > 4 mL in 1 CUP, UNIT-DOSE (0121-0892-63) 5 tray2020-03-260000-00-00NoNoCurrent
0121-0892-63001210892634 mL in 1 CUP, UNIT-DOSE (0121-0892-63) 4 ml2004-04-08NoNoHistorical