FDA.reportPublic FDA data

terbinafine hydrochloride

Product NDC
71335-9677
11-digit product format
713359677
Labeler code
71335
Product ID
71335-9677_ebbb6769-54f5-415e-a685-0c6baf35645d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
terbinafine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078163
Marketing category
ANDA
Marketing start
2022-01-28
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
terbinafine hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERBINAFINE HYDROCHLORIDE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii012C11ZU6G
Rxcui313222

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
55a24767-1759-5f6a-8888-ea4aa0adac21Product name120140508
db9701af-cb4f-b8ba-d282-6bc5b6b7c467Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-9677-1terbinafine hydrochloride30 in 1 BOTTLE, PLASTICTABLET30104
71335-9677-2terbinafine hydrochloride60 in 1 BOTTLE, PLASTICTABLET60104
71335-9677-3terbinafine hydrochloride90 in 1 BOTTLE, PLASTICTABLET90104
71335-9677-4terbinafine hydrochloride100 in 1 BOTTLE, PLASTICTABLET100104
71335-9677-5terbinafine hydrochloride7 in 1 BOTTLE, PLASTICTABLET7104
71335-9677-6terbinafine hydrochloride40 in 1 BOTTLE, PLASTICTABLET40104
71335-9677-7terbinafine hydrochloride45 in 1 BOTTLE, PLASTICTABLET45104
71335-9677-8terbinafine hydrochloride14 in 1 BOTTLE, PLASTICTABLET14104
71335-9677-9terbinafine hydrochloride28 in 1 BOTTLE, PLASTICTABLET28104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9677TERBINAFINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]104Current NDC, 9 package rows20250303_5a921005-304e-4f5b-b9ba-681749e2499b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSN5a921005-304e-4f5b-b9ba-681749e2499b104
313222terbinafine 250 MG Oral TabletSCD5a921005-304e-4f5b-b9ba-681749e2499b104
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY5a921005-304e-4f5b-b9ba-681749e2499b104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9677-17133596770130 TABLET in 1 BOTTLE, PLASTIC (71335-9677-1) 30 tablet2023-06-06NoNoHistorical
71335-9677-27133596770260 TABLET in 1 BOTTLE, PLASTIC (71335-9677-2) 60 tablet2025-02-03NoNoHistorical
71335-9677-37133596770390 TABLET in 1 BOTTLE, PLASTIC (71335-9677-3) 90 tablet2023-08-30NoNoHistorical
71335-9677-471335967704100 TABLET in 1 BOTTLE, PLASTIC (71335-9677-4) 100 tablet2025-02-03NoNoHistorical
71335-9677-5713359677057 TABLET in 1 BOTTLE, PLASTIC (71335-9677-5) 7 tablet2025-02-03NoNoHistorical
71335-9677-67133596770640 TABLET in 1 BOTTLE, PLASTIC (71335-9677-6) 40 tablet2025-02-03NoNoHistorical
71335-9677-77133596770745 TABLET in 1 BOTTLE, PLASTIC (71335-9677-7) 45 tablet2023-06-26NoNoHistorical
71335-9677-87133596770814 TABLET in 1 BOTTLE, PLASTIC (71335-9677-8) 14 tablet2023-05-10NoNoHistorical
71335-9677-97133596770928 TABLET in 1 BOTTLE, PLASTIC (71335-9677-9) 28 tablet2023-05-10NoNoHistorical