FDA.reportPublic FDA data

Terbinafine Hydrochloride

Product NDC
31722-209
11-digit product format
317220209
Labeler code
31722
Product ID
31722-209_f3186a46-2fe9-4e3e-bb0a-f8dc4412ad30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terbinafine
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA077533
Marketing category
ANDA
Marketing start
2011-01-01
Marketing end
0000-00-00
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
250 1/1
Pharmacologic classes
Allylamine [CS],Allylamine Antifungal [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
31722-209-012020-01-31C16284748780-19d75b9d0-c889-f424-e053-dadaa90a57ceTerbinafine tablets, USP 250 mg for oral use These highlights do not include all the information needed to use Terbinafine Hydrochloride safely and effectively. See full prescribing information for Terbinafine Hydrochloride. Terbinafine Hydrochloride (Terbinafine Hydrochloride) TABLET for ORAL use. Initial U.S. Approval: 1992
31722-209-052020-01-31C16284748780-19d75b9d0-c889-f424-e053-dadaa90a57ceTerbinafine tablets, USP 250 mg for oral use These highlights do not include all the information needed to use Terbinafine Hydrochloride safely and effectively. See full prescribing information for Terbinafine Hydrochloride. Terbinafine Hydrochloride (Terbinafine Hydrochloride) TABLET for ORAL use. Initial U.S. Approval: 1992
31722-209-302020-01-31C16284748780-19d75b9d0-c889-f424-e053-dadaa90a57ceTerbinafine tablets, USP 250 mg for oral use These highlights do not include all the information needed to use Terbinafine Hydrochloride safely and effectively. See full prescribing information for Terbinafine Hydrochloride. Terbinafine Hydrochloride (Terbinafine Hydrochloride) TABLET for ORAL use. Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-209-01Terbinafine Hydrochloride100 in 1 BOTTLETABLET1006
31722-209-05Terbinafine Hydrochloride500 in 1 BOTTLETABLET5006
31722-209-30Terbinafine Hydrochloride30 in 1 BOTTLETABLET306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-209-01EA - Each31722-20998c6be4a-d142-42b9-a1e7-55b556c0fcfb12012-07-24
31722-209-30EA - Each31722-20926f8e695-2f03-4203-a277-b6d4241f81af12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TERBINAFINE HYDROCHLORIDEACTIVE INGREDIENT012C11ZU6GTERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CAMBER PHARMACEUTICALS, INC.]6
TERBINAFINEACTIVE MOIETYG7RIW8S0XPTERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CAMBER PHARMACEUTICALS, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CAMBER PHARMACEUTICALS, INC.]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CAMBER PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CAMBER PHARMACEUTICALS, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CAMBER PHARMACEUTICALS, INC.]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CAMBER PHARMACEUTICALS, INC.]6
TERBINAFINE HYDROCHLORIDEACTIVE INGREDIENT012C11ZU6GTERBINAFINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
TERBINAFINEACTIVE MOIETYG7RIW8S0XPTERBINAFINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTERBINAFINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTERBINAFINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TERBINAFINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TERBINAFINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TERBINAFINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3
TERBINAFINE HYDROCHLORIDEACTIVE INGREDIENT012C11ZU6GTERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT]2
TERBINAFINEACTIVE MOIETYG7RIW8S0XPTERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-209TERBINAFINE HYDROCHLORIDE (TERBINAFINE) TABLET [CAMBER PHARMACEUTICALS, INC.]6Legacy NDC, 3 package rows20150416_bcf7e761-786b-4ac8-aecd-ea1c745880b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313222terbinafine HCl 250 MG Oral TabletPSNbcf7e761-786b-4ac8-aecd-ea1c745880b16
313222terbinafine HCl 250 MG Oral TabletPSNd3592751-686b-48bd-a8d4-14c86bbcf5106
313222terbinafine 250 MG Oral TabletSCDbcf7e761-786b-4ac8-aecd-ea1c745880b16
313222terbinafine 250 MG Oral TabletSCDd3592751-686b-48bd-a8d4-14c86bbcf5106
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSYbcf7e761-786b-4ac8-aecd-ea1c745880b16
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSYd3592751-686b-48bd-a8d4-14c86bbcf5106
313222terbinafine HCl 250 MG Oral TabletPSN984ad737-0cfe-4bee-888d-3a07b23cb7cd2
313222terbinafine 250 MG Oral TabletSCD984ad737-0cfe-4bee-888d-3a07b23cb7cd2
313222terbinafine (as terbinafine HCl) 250 MG Oral TabletSY984ad737-0cfe-4bee-888d-3a07b23cb7cd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
31722-209-0131722020901100 in 1 BOTTLEHistorical
31722-209-0531722020905500 in 1 BOTTLEHistorical
31722-209-303172202093030 in 1 BOTTLEHistorical