FDA.reportPublic FDA data

Phenytoin

Product NDC
64980-573
11-digit product format
649800573
Labeler code
64980
Product ID
64980-573_14ec4c18-fa7a-46e6-ac18-a7c23253e51c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Phenytoin
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA200691
Marketing category
ANDA
Marketing start
2024-05-03
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
Listing expiration
2026-12-31

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
64980-573-01Phenytoin100 in 1 BOTTLETABLET, CHEWABLE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-573-01EA - Each64980-573add3b1cc-ee20-4a11-a20b-4ddd0e9a5ef412024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-573PHENYTOIN TABLET, CHEWABLE [RISING PHARMA HOLDINGS, INC.]1Current NDC, 1 package rows20240504_e95cad66-b5f9-4802-a35f-fed340bf09ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1313885phenytoin 50 MG Chewable TabletPSNe95cad66-b5f9-4802-a35f-fed340bf09ab1
1313885phenytoin 50 MG Chewable TabletSCDe95cad66-b5f9-4802-a35f-fed340bf09ab1
1313885DPH 50 MG Chewable TabletSYe95cad66-b5f9-4802-a35f-fed340bf09ab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
64980-573-0164980057301100 TABLET, CHEWABLE in 1 BOTTLE (64980-573-01) 2024-05-03NoNoCurrent