FDA.reportPublic FDA data

terbinafine hydrochloride

Product NDC
70518-3907
11-digit product format
705183907
Labeler code
70518
Product ID
70518-3907_4d26c515-0886-5b32-e063-6294a90a9ebb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
terbinafine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078163
Marketing category
ANDA
Marketing start
2023-11-03
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
250 mg/1
Pharmacologic classes
Allylamine Antifungal [EPC], Allylamine [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
terbinafine hydrochloride
Listing expiration
2027-12-31

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
70518-3907-0terbinafine hydrochloride90 in 1 BOTTLE, PLASTICTABLET906
70518-3907-1terbinafine hydrochloride30 in 1 BOTTLE, PLASTICTABLET306
70518-3907-2terbinafine hydrochloride45 in 1 BOTTLE, PLASTICTABLET456
70518-3907-3terbinafine hydrochloride30 in 1 BLISTER PACKTABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3907TERBINAFINE HYDROCHLORIDE TABLET [REMEDYREPACK INC.]4Current NDC, 4 package rows20240510_2886b2ff-815f-4621-bc28-1fea082c1920.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSN2886b2ff-815f-4621-bc28-1fea082c19206
313222terbinafine 250 MG Oral TabletSCD2886b2ff-815f-4621-bc28-1fea082c19206
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY2886b2ff-815f-4621-bc28-1fea082c19206

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3907-07051839070090 in 1 BOTTLE, PLASTICHistorical
70518-3907-17051839070130 in 1 BOTTLE, PLASTICHistorical
70518-3907-27051839070245 in 1 BOTTLE, PLASTICHistorical
70518-3907-37051839070330 TABLET in 1 BLISTER PACK (70518-3907-3) 30 tablet2026-03-16NoNoHistorical