FDA.reportPublic FDA data

Phenytoin

Product NDC
70518-0841
11-digit product format
705180841
Labeler code
70518
Product ID
70518-0841_522f9466-a36b-e74a-e063-6394a90af379
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA200565
Marketing category
ANDA
Marketing start
2017-11-10
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phenytoin
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
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
70518-0841-0Phenytoin30 in 1 BLISTER PACKTABLET, CHEWABLE3017
70518-0841-1Phenytoin100 in 1 BOXTABLET, CHEWABLE10017
70518-0841-2Phenytoin1 in 1 POUCHTABLET, CHEWABLE117
70518-0841-3Phenytoin50 in 1 BOXTABLET, CHEWABLE5017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0841PHENYTOIN TABLET, CHEWABLE [REMEDYREPACK INC.]12Current NDC, Legacy NDC, 4 package rows20250503_31e8a777-75b1-4f48-9682-0bcc3189ad26.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1313885phenytoin 50 MG Chewable TabletPSN31e8a777-75b1-4f48-9682-0bcc3189ad2617
1313885phenytoin 50 MG Chewable TabletSCD31e8a777-75b1-4f48-9682-0bcc3189ad2617
1313885DPH 50 MG Chewable TabletSY31e8a777-75b1-4f48-9682-0bcc3189ad2617

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0841-07051808410030 TABLET, CHEWABLE in 1 BLISTER PACK (70518-0841-0) 2017-11-100000-00-00NoNoCurrent
70518-0841-170518084101100 POUCH in 1 BOX (70518-0841-1) > 1 TABLET, CHEWABLE in 1 POUCH (70518-0841-2) 100 pouch2022-01-050000-00-00NoNoCurrent
70518-0841-2705180841021 in 1 POUCHHistorical
70518-0841-37051808410350 POUCH in 1 BOX (70518-0841-3) / 1 TABLET, CHEWABLE in 1 POUCH (70518-0841-2) 50 pouch2026-04-25NoNoCurrent