FDA.reportPublic FDA data

terbinafine hydrochloride

Product NDC
71335-1836
11-digit product format
713351836
Labeler code
71335
Product ID
71335-1836_754f22ba-65af-4d03-bdc2-456e69dea493
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
terbinafine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078163
Marketing category
ANDA
Marketing start
2020-10-01
Marketing end
0000-00-00
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
71335-1836-1terbinafine hydrochloride30 in 1 BOTTLE, PLASTICTABLET30102
71335-1836-2terbinafine hydrochloride60 in 1 BOTTLE, PLASTICTABLET60102
71335-1836-3terbinafine hydrochloride90 in 1 BOTTLE, PLASTICTABLET90102
71335-1836-4terbinafine hydrochloride100 in 1 BOTTLE, PLASTICTABLET100102
71335-1836-5terbinafine hydrochloride7 in 1 BOTTLE, PLASTICTABLET7102
71335-1836-6terbinafine hydrochloride40 in 1 BOTTLE, PLASTICTABLET40102
71335-1836-7terbinafine hydrochloride45 in 1 BOTTLE, PLASTICTABLET45102
71335-1836-8terbinafine hydrochloride14 in 1 BOTTLE, PLASTICTABLET14102
71335-1836-9terbinafine hydrochloride28 in 1 BOTTLE, PLASTICTABLET28102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1836TERBINAFINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]102Legacy NDC, 9 package rows20231201_754f22ba-65af-4d03-bdc2-456e69dea493.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSN754f22ba-65af-4d03-bdc2-456e69dea493102
313222terbinafine 250 MG Oral TabletSCD754f22ba-65af-4d03-bdc2-456e69dea493102
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY754f22ba-65af-4d03-bdc2-456e69dea493102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1836-17133518360130 TABLET in 1 BOTTLE, PLASTIC (71335-1836-1) 30 tablet2021-04-290000-00-00NoNoCurrent
71335-1836-27133518360260 TABLET in 1 BOTTLE, PLASTIC (71335-1836-2) 60 tablet2021-04-290000-00-00NoNoCurrent
71335-1836-37133518360390 TABLET in 1 BOTTLE, PLASTIC (71335-1836-3) 90 tablet2021-04-290000-00-00NoNoCurrent
71335-1836-471335183604100 TABLET in 1 BOTTLE, PLASTIC (71335-1836-4) 100 tablet2021-04-290000-00-00NoNoCurrent
71335-1836-5713351836057 TABLET in 1 BOTTLE, PLASTIC (71335-1836-5) 7 tablet2021-04-290000-00-00NoNoCurrent
71335-1836-67133518360640 TABLET in 1 BOTTLE, PLASTIC (71335-1836-6) 40 tablet2021-04-290000-00-00NoNoCurrent
71335-1836-77133518360745 TABLET in 1 BOTTLE, PLASTIC (71335-1836-7) 45 tablet2021-04-290000-00-00NoNoCurrent
71335-1836-87133518360814 TABLET in 1 BOTTLE, PLASTIC (71335-1836-8) 14 tablet2021-04-290000-00-00NoNoCurrent
71335-1836-97133518360928 TABLET in 1 BOTTLE, PLASTIC (71335-1836-9) 28 tablet2021-04-290000-00-00NoNoCurrent