FDA.reportPublic FDA data

Phenytoin Infatabs

Product NDC
66993-372
11-digit product format
669930372
Labeler code
66993
Product ID
66993-372_e2f4f249-b837-4362-8854-a6c3960e1f94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Prasco Laboratories
Application
ANDA084427
Marketing category
ANDA
Marketing start
2021-11-23
Substance
PHENYTOIN
Active strength
50 mg/1
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 Infatabs
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYTOIN50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6158TKW0C5
Rxcui1313885

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
be8c0c29-be12-4cae-8e3b-1c71ed6b952cProduct name220250626
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
66993-372-02Phenytoin Infatabs100 in 1 BOTTLETABLET, CHEWABLE1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66993-372-02EA - Each66993-3724d8029f4-1742-42ae-b491-d0e02338d72f12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66993-372PHENYTOIN INFATABS (PHENYTOIN) TABLET, CHEWABLE [PRASCO LABORATORIES]5Current NDC, Legacy NDC, 1 package rows20250122_3580e6a8-f7c3-44a0-a1eb-2a84ae589d21.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1313885phenytoin 50 MG Chewable TabletPSN3580e6a8-f7c3-44a0-a1eb-2a84ae589d217
1313885phenytoin 50 MG Chewable TabletSCD3580e6a8-f7c3-44a0-a1eb-2a84ae589d217
1313885DPH 50 MG Chewable TabletSY3580e6a8-f7c3-44a0-a1eb-2a84ae589d217
1313885phenytoin 50 MG Chewable TabletPSN0d240b2b-bc5c-4989-a20b-54ed37a09a4f6
1313885phenytoin 50 MG Chewable TabletSCD0d240b2b-bc5c-4989-a20b-54ed37a09a4f6
1313885DPH 50 MG Chewable TabletSY0d240b2b-bc5c-4989-a20b-54ed37a09a4f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
66993-372-0266993037202100 TABLET, CHEWABLE in 1 BOTTLE (66993-372-02) 2021-11-230000-00-00NoNoCurrent