Terbinafine Hydrochloride

Product NDC
0363-2083
11-digit product format
003632083
Labeler code
0363
Product ID
0363-2083_aab4fe7d-4fa1-4751-b681-3d041dc116ce
Type
HUMAN OTC DRUG
Nonproprietary name
Terbinafine Hydrochloride
Dosage form
CREAM
Route
TOPICAL
Labeler
Walgreen Company
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
0363-2083-012025-07-29C16284748780-13b156c62-2a56-fb37-e063-e6dba90a4e07Terbinafine Hydrochloride

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-2083-01Terbinafine Hydrochloride15 g in 1 TUBECREAM152
0363-2083-01Terbinafine Hydrochloride1 in 1 CARTONCREAM12

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-2083TERBINAFINE HYDROCHLORIDE CREAM [WALGREEN COMPANY]2Legacy NDC, 2 package rows20170718_d985c2a4-c0e8-4d87-9fcd-2b1aeda0198e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992528terbinafine HCl 1 % Topical CreamPSNd985c2a4-c0e8-4d87-9fcd-2b1aeda0198e2
992528terbinafine hydrochloride 10 MG/ML Topical CreamSCDd985c2a4-c0e8-4d87-9fcd-2b1aeda0198e2
992528terbinafine hydrochloride 1 % Topical CreamSYd985c2a4-c0e8-4d87-9fcd-2b1aeda0198e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-2083-01003632083011 TUBE in 1 CARTON (0363-2083-01) > 15 g in 1 TUBE1 tube2012-12-120000-00-00NoNoCurrent