Terbinafine

Product NDC
71335-1668
11-digit product format
713351668
Labeler code
71335
Product ID
71335-1668_d49c72a0-7653-46c8-aa3f-968ac35888ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077533
Marketing category
ANDA
Marketing start
2016-06-27
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
71335-1668-1Terbinafine30 in 1 BOTTLETABLET305
71335-1668-2Terbinafine60 in 1 BOTTLETABLET605
71335-1668-3Terbinafine90 in 1 BOTTLETABLET905
71335-1668-4Terbinafine100 in 1 BOTTLETABLET1005
71335-1668-5Terbinafine7 in 1 BOTTLETABLET75
71335-1668-6Terbinafine40 in 1 BOTTLETABLET405
71335-1668-7Terbinafine45 in 1 BOTTLETABLET455
71335-1668-8Terbinafine14 in 1 BOTTLETABLET145
71335-1668-9Terbinafine28 in 1 BOTTLETABLET285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1668TERBINAFINE TABLET [BRYANT RANCH PREPACK]5Legacy NDC, 9 package rows20250115_d6d9c5ec-440a-4700-8a52-d6bf6d6d90a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSNd6d9c5ec-440a-4700-8a52-d6bf6d6d90a55
313222terbinafine 250 MG Oral TabletSCDd6d9c5ec-440a-4700-8a52-d6bf6d6d90a55
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSYd6d9c5ec-440a-4700-8a52-d6bf6d6d90a55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1668-17133516680130 TABLET in 1 BOTTLE (71335-1668-1) 30 tablet2020-07-280000-00-00NoNoCurrent
71335-1668-27133516680260 TABLET in 1 BOTTLE (71335-1668-2) 60 tablet2022-02-140000-00-00NoNoCurrent
71335-1668-37133516680390 TABLET in 1 BOTTLE (71335-1668-3) 90 tablet2020-10-130000-00-00NoNoCurrent
71335-1668-471335166804100 TABLET in 1 BOTTLE (71335-1668-4) 100 tablet2020-07-210000-00-00NoNoCurrent
71335-1668-5713351668057 TABLET in 1 BOTTLE (71335-1668-5) 7 tablet2020-07-210000-00-00NoNoCurrent
71335-1668-67133516680640 TABLET in 1 BOTTLE (71335-1668-6) 40 tablet2021-12-280000-00-00NoNoCurrent
71335-1668-77133516680745 TABLET in 1 BOTTLE (71335-1668-7) 45 tablet2020-07-200000-00-00NoNoCurrent
71335-1668-87133516680814 TABLET in 1 BOTTLE (71335-1668-8) 14 tablet2020-08-100000-00-00NoNoCurrent
71335-1668-97133516680928 TABLET in 1 BOTTLE (71335-1668-9) 28 tablet2022-02-140000-00-00NoNoCurrent