FDA.reportPublic FDA data

Terbinafine Hydrochloride

Product NDC
51672-2080
11-digit product format
516722080
Labeler code
51672
Product ID
51672-2080_4b425c57-bf63-6851-e063-6394a90ac6e7
Type
HUMAN OTC DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077511
Marketing category
ANDA
Marketing start
2007-07-02
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
1 g/100g
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 HYDROCHLORIDE1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii012C11ZU6G
Rxcui992528

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
51672-2080-1Terbinafine Hydrochloride15 g in 1 TUBECREAM156
51672-2080-1Terbinafine Hydrochloride1 in 1 CARTONCREAM16
51672-2080-2Terbinafine Hydrochloride30 g in 1 TUBECREAM306
51672-2080-2Terbinafine Hydrochloride1 in 1 CARTONCREAM16
51672-2080-3Terbinafine Hydrochloride60 g in 1 TUBECREAM606
51672-2080-3Terbinafine Hydrochloride1 in 1 CARTONCREAM16
51672-2080-4Terbinafine Hydrochloride1 in 1 CARTONCREAM16
51672-2080-4Terbinafine Hydrochloride15 g in 1 TUBECREAM156
51672-2080-6Terbinafine Hydrochloride1 in 1 CARTONCREAM16
51672-2080-6Terbinafine Hydrochloride45 g in 1 TUBECREAM456
51672-2080-8Terbinafine Hydrochloride1 in 1 CARTONCREAM16
51672-2080-8Terbinafine Hydrochloride12 g in 1 TUBECREAM126
51672-2080-9Terbinafine Hydrochloride1 in 1 CARTONCREAM16
51672-2080-9Terbinafine Hydrochloride24 g in 1 TUBECREAM246

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2080-1GM - Gram51672-20805b077eb2-4a3e-4467-b213-af80bebdfea212012-07-24
51672-2080-2GM - Gram51672-2080b99b56d3-5b68-429b-b864-d7cef0ee297012012-07-24
51672-2080-8GM - Gram51672-2080250969be-c2ab-423f-9beb-f2c9d68abc0512012-07-24
51672-2080-9GM - Gram51672-2080b03e439e-fc3f-496d-b719-b958636880ea12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Terbinafine HydrochlorideACTIVE INGREDIENT012C11ZU6GTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
TerbinafineACTIVE MOIETYG7RIW8S0XPTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
cetyl alcoholINACTIVE INGREDIENT936JST6JCNTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08XTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
sodium hydroxideINACTIVE INGREDIENT55X04QC32ITERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RTERBINAFINE HYDROCHLORIDE CREAM [PHYSICIANS TOTAL CARE, INC.]2
Terbinafine HydrochlorideACTIVE INGREDIENT012C11ZU6GTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
Terbinafine HydrochlorideACTIVE INGREDIENT012C11ZU6GTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
Terbinafine HydrochlorideACTIVE INGREDIENT012C11ZU6GTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
TerbinafineACTIVE MOIETYG7RIW8S0XPTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
TerbinafineACTIVE MOIETYG7RIW8S0XPTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
TerbinafineACTIVE MOIETYG7RIW8S0XPTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08XTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08XTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08XTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ITERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ITERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ITERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1
waterINACTIVE INGREDIENT059QF0KO0RTERBINAFINE HYDROCHLORIDE CREAM [PROFICIENT RX LP]1
waterINACTIVE INGREDIENT059QF0KO0RTERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC]1
waterINACTIVE INGREDIENT059QF0KO0RTERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2080TERBINAFINE HYDROCHLORIDE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3Current NDC, Legacy NDC, 14 package rows20210304_92b31fc4-0f02-4857-b11f-49b9f942ee84.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992528terbinafine HCl 1 % Topical CreamPSNef8370dc-8ca4-411d-87e1-dc6af319133014
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCDef8370dc-8ca4-411d-87e1-dc6af319133014
992528terbinafine hydrochloride 1 % Topical CreamSYef8370dc-8ca4-411d-87e1-dc6af319133014
992528terbinafine HCl 1 % Topical CreamPSN6016e546-6c02-4af0-888c-c0899865c5f09
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD6016e546-6c02-4af0-888c-c0899865c5f09
992528terbinafine hydrochloride 1 % Topical CreamSY6016e546-6c02-4af0-888c-c0899865c5f09
992528terbinafine HCl 1 % Topical CreamPSN92b31fc4-0f02-4857-b11f-49b9f942ee846
992528terbinafine HCl 1 % Topical CreamPSN76f7525d-2005-4da8-a795-50ede6236c686
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD92b31fc4-0f02-4857-b11f-49b9f942ee846
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD76f7525d-2005-4da8-a795-50ede6236c686
992528terbinafine hydrochloride 1 % Topical CreamSY92b31fc4-0f02-4857-b11f-49b9f942ee846
992528terbinafine hydrochloride 1 % Topical CreamSY76f7525d-2005-4da8-a795-50ede6236c686
992528terbinafine HCl 1 % Topical CreamPSN89afb1dc-a236-4154-b8b5-2cab6ad421c85
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD89afb1dc-a236-4154-b8b5-2cab6ad421c85
992528terbinafine hydrochloride 1 % Topical CreamSY89afb1dc-a236-4154-b8b5-2cab6ad421c85
992528terbinafine HCl 1 % Topical CreamPSNba1f253f-021b-4857-b015-a72aa9df2d832
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCDba1f253f-021b-4857-b015-a72aa9df2d832
992528terbinafine hydrochloride 1 % Topical CreamSYba1f253f-021b-4857-b015-a72aa9df2d832

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-2080-1516722080011 TUBE in 1 CARTON (51672-2080-1) / 15 g in 1 TUBE1 tube2007-07-020000-00-00NoNoCurrent
51672-2080-2516722080021 TUBE in 1 CARTON (51672-2080-2) / 30 g in 1 TUBE1 tube2007-07-020000-00-00NoNoCurrent
51672-2080-3516722080031 TUBE in 1 CARTON (51672-2080-3) / 60 g in 1 TUBE1 tube2007-07-020000-00-00NoNoCurrent
51672-2080-4516722080041 TUBE in 1 CARTON (51672-2080-4) / 15 g in 1 TUBE1 tube2017-04-240000-00-00NoNoCurrent
51672-2080-6516722080061 TUBE in 1 CARTON (51672-2080-6) / 45 g in 1 TUBE1 tube2007-07-020000-00-00NoNoCurrent
51672-2080-8516722080081 TUBE in 1 CARTON (51672-2080-8) / 12 g in 1 TUBE1 tube2007-07-020000-00-00NoNoCurrent
51672-2080-9516722080091 TUBE in 1 CARTON (51672-2080-9) / 24 g in 1 TUBE1 tube2007-07-020000-00-00NoNoCurrent