TERCONAZOLE

Product NDC
52959-811
11-digit product format
529590811
Labeler code
52959
Product ID
52959-811_efdfe922-d360-43bc-b65c-245178658b4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
terconazole
Dosage form
CREAM
Route
VAGINAL
Labeler
H.J. Harkins Company, Inc.
Application
NDA019579
Marketing category
NDA
Marketing start
2004-04-01
Marketing end
0000-00-00
Substance
TERCONAZOLE
Active strength
4 mg/g
Pharmacologic classes
Azole Antifungal [EPC],Azoles [CS]
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
a1f2acc3-46a1-8c88-4468-5826c2e9fea6Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-811-032019-11-13C16284748780-197449f38-d4bd-f6ea-e053-dbdaa90aa703TERCONAZOLE VAGINAL CREAM 0.4% 7-Day Regimen TERCONAZOLE VAGINAL CREAM 0.4% 3-Day Regimen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-811-03TERCONAZOLE45 g in 1 TUBE, WITH APPLICATORCREAM453

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-811-03GM - Gram52959-811ffbccabd-2264-4d86-acb4-63ada84fdd0112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TERCONAZOLEACTIVE INGREDIENT0KJ2VE664UTERCONAZOLE CREAM [H.J. HARKINS COMPANY, INC.]3
TERCONAZOLEACTIVE MOIETY0KJ2VE664UTERCONAZOLE CREAM [H.J. HARKINS COMPANY, INC.]3
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UTERCONAZOLE CREAM [H.J. HARKINS COMPANY, INC.]3
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNTERCONAZOLE CREAM [H.J. HARKINS COMPANY, INC.]3
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSTERCONAZOLE CREAM [H.J. HARKINS COMPANY, INC.]3
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MTERCONAZOLE CREAM [H.J. HARKINS COMPANY, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTERCONAZOLE CREAM [H.J. HARKINS COMPANY, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TERCONAZOLE CREAM [H.J. HARKINS COMPANY, INC.]3
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YTERCONAZOLE CREAM [H.J. HARKINS COMPANY, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RTERCONAZOLE CREAM [H.J. HARKINS COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-811TERCONAZOLE CREAM [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 1 package rows20120120_426c71b4-39cf-4d12-ad6a-8f64a7c15490.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313226terconazole 0.4 % Vaginal CreamPSN426c71b4-39cf-4d12-ad6a-8f64a7c154903
313226terconazole 4 MG/ML Vaginal CreamSCD426c71b4-39cf-4d12-ad6a-8f64a7c154903
313226terconazole 0.4 % Vaginal CreamSY426c71b4-39cf-4d12-ad6a-8f64a7c154903

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
52959-811-035295908110345 g in 1 TUBE, WITH APPLICATOR45 gHistorical