FDA.reportPublic FDA data

Terbinafine Hydrochloride

Product NDC
68016-080
11-digit product format
680160080
Labeler code
68016
Product ID
68016-080_1cc3144f-5f7f-42cb-92c4-b6d026a0cc20
Type
HUMAN OTC DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Pharmacy Value Alliance LLC
Application
ANDA077511
Marketing category
ANDA
Marketing start
2007-07-02
Marketing end
0000-00-00
Substance
TERBINAFINE HYDROCHLORIDE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2020-12-31
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
68016-080-022025-07-29C16284748780-13b156c62-2927-fb37-e063-e6dba90a4e07Terbinafine Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-080-02Terbinafine Hydrochloride1 in 1 CARTONCREAM12
68016-080-02Terbinafine Hydrochloride30 g in 1 TUBECREAM302

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Terbinafine HydrochlorideACTIVE INGREDIENT012C11ZU6GTERBINAFINE HYDROCHLORIDE CREAM [CHAIN DRUG CONSTORTIUM]1
TerbinafineACTIVE MOIETYG7RIW8S0XPTERBINAFINE HYDROCHLORIDE CREAM [CHAIN DRUG CONSTORTIUM]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHTERBINAFINE HYDROCHLORIDE CREAM [CHAIN DRUG CONSTORTIUM]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNTERBINAFINE HYDROCHLORIDE CREAM [CHAIN DRUG CONSTORTIUM]1
cetyl palmitateINACTIVE INGREDIENT5ZA2S6B08XTERBINAFINE HYDROCHLORIDE CREAM [CHAIN DRUG CONSTORTIUM]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSTERBINAFINE HYDROCHLORIDE CREAM [CHAIN DRUG CONSTORTIUM]1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MTERBINAFINE HYDROCHLORIDE CREAM [CHAIN DRUG CONSTORTIUM]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ITERBINAFINE HYDROCHLORIDE CREAM [CHAIN DRUG CONSTORTIUM]1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58XTERBINAFINE HYDROCHLORIDE CREAM [CHAIN DRUG CONSTORTIUM]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YTERBINAFINE HYDROCHLORIDE CREAM [CHAIN DRUG CONSTORTIUM]1
waterINACTIVE INGREDIENT059QF0KO0RTERBINAFINE HYDROCHLORIDE CREAM [CHAIN DRUG CONSTORTIUM]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-080TERBINAFINE HYDROCHLORIDE CREAM [PHARMACY VALUE ALLIANCE LLC]2Legacy NDC, 2 package rows20170512_7037e539-118a-4b8f-9d87-e57bfc142649.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992528terbinafine HCl 1 % Topical CreamPSN7037e539-118a-4b8f-9d87-e57bfc1426492
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCD7037e539-118a-4b8f-9d87-e57bfc1426492
992528terbinafine hydrochloride 1 % Topical CreamSY7037e539-118a-4b8f-9d87-e57bfc1426492

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-080-02680160080021 TUBE in 1 CARTON (68016-080-02) > 30 g in 1 TUBE1 tube2007-07-020000-00-00NoNoCurrent