FDA.reportPublic FDA data

Phenytoin

Product NDC
51672-4146
11-digit product format
516724146
Labeler code
51672
Product ID
51672-4146_4e03fb7d-d33a-2472-e063-6394a90a9b81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA200565
Marketing category
ANDA
Marketing start
2014-04-17
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
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
51672-4146-1Phenytoin100 in 1 BOTTLETABLET, CHEWABLE10013
51672-4146-3Phenytoin1000 in 1 BOTTLETABLET, CHEWABLE100013
51672-4146-6Phenytoin30 in 1 BOTTLETABLET, CHEWABLE3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4146-1EA - Each51672-4146cc471fd7-aa57-418d-af8a-92f796dded6c12014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PhenytoinACTIVE INGREDIENT6158TKW0C5PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]5
PhenytoinACTIVE MOIETY6158TKW0C5PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]5
aluminum oxideINACTIVE INGREDIENTLMI26O6933PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]5
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GPHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]5
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]5
HypromellosesINACTIVE INGREDIENT3NXW29V3WOPHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]5
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]5
Magnesium StearateINACTIVE INGREDIENT70097M6I30PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]5
Saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYPHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]5
SucroseINACTIVE INGREDIENTC151H8M554PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]5
TalcINACTIVE INGREDIENT7SEV7J4R1UPHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]5
PhenytoinACTIVE INGREDIENT6158TKW0C5PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]1
PhenytoinACTIVE MOIETY6158TKW0C5PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]1
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GPHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]1
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]1
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KPHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]1
Lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XPHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]1
Saccharin sodiumINACTIVE INGREDIENTSB8ZUX40TYPHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]1
SucroseINACTIVE INGREDIENTC151H8M554PHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]1
TalcINACTIVE INGREDIENT7SEV7J4R1UPHENYTOIN TABLET, CHEWABLE [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4146PHENYTOIN TABLET, CHEWABLE [TARO PHARMACEUTICALS U.S.A., INC]11Current NDC, Legacy NDC, 3 package rows20220702_78b38e7b-1460-4adc-b738-320ffa6259c2.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
1313885phenytoin 50 MG Chewable TabletPSN78b38e7b-1460-4adc-b738-320ffa6259c213
1313885phenytoin 50 MG Chewable TabletSCD78b38e7b-1460-4adc-b738-320ffa6259c213
1313885DPH 50 MG Chewable TabletSY78b38e7b-1460-4adc-b738-320ffa6259c213
1313885phenytoin 50 MG Chewable TabletPSN352007dd-0587-4597-8338-c13eda4c5d638
1313885phenytoin 50 MG Chewable TabletSCD352007dd-0587-4597-8338-c13eda4c5d638
1313885DPH 50 MG Chewable TabletSY352007dd-0587-4597-8338-c13eda4c5d638
1313885phenytoin 50 MG Chewable TabletPSN08a9d26b-4419-43ec-98f3-43d4534c2e764
1313885phenytoin 50 MG Chewable TabletSCD08a9d26b-4419-43ec-98f3-43d4534c2e764
1313885DPH 50 MG Chewable TabletSY08a9d26b-4419-43ec-98f3-43d4534c2e764
1313885phenytoin 50 MG Chewable TabletPSN98bd1d9f-b1a4-49eb-a0b4-a790265710dd1
1313885phenytoin 50 MG Chewable TabletSCD98bd1d9f-b1a4-49eb-a0b4-a790265710dd1
1313885DPH 50 MG Chewable TabletSY98bd1d9f-b1a4-49eb-a0b4-a790265710dd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51672-4146-151672414601100 TABLET, CHEWABLE in 1 BOTTLE (51672-4146-1) 2014-04-170000-00-00NoNoCurrent
51672-4146-3516724146031000 TABLET, CHEWABLE in 1 BOTTLE (51672-4146-3) 2014-04-170000-00-00NoNoCurrent
51672-4146-65167241460630 TABLET, CHEWABLE in 1 BOTTLE (51672-4146-6) 2014-04-170000-00-00NoNoCurrent