FDA.reportPublic FDA data

Terbinafine

Product NDC
70518-2941
11-digit product format
705182941
Labeler code
70518
Product ID
70518-2941_4ab97e93-0067-21d7-e063-6294a90ae00d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078297
Marketing category
ANDA
Marketing start
2020-11-13
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2941-02022-02-09C16284748780-1d6a99b39-ccd8-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use TERBINAFINE TABLETS safely and effectively. See full prescribing information for TERBINAFINE TABLETS. TERBINAFINE tablets, for oral use Initial U.S. Approval: 1992
70518-2941-02022-01-28C16284748780-1d6a99b39-ccd8-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use TERBINAFINE TABLETS safely and effectively. See full prescribing information for TERBINAFINE TABLETS. TERBINAFINE tablets, for oral use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2941-0Terbinafine30 in 1 BLISTER PACKTABLET305

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSN44c6f6e7-e0c0-450e-83ce-1ed4f3efddec5
313222terbinafine 250 MG Oral TabletSCD44c6f6e7-e0c0-450e-83ce-1ed4f3efddec5
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY44c6f6e7-e0c0-450e-83ce-1ed4f3efddec5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2941-07051829410030 TABLET in 1 BLISTER PACK (70518-2941-0) 30 tablet2020-11-130000-00-00NoNoCurrent