TERCONAZOLE

Product NDC
55045-3259
11-digit product format
550453259
Labeler code
55045
Product ID
55045-3259_bce76198-3fdc-482e-8c03-31fd4e134aeb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
terconazole
Dosage form
CREAM
Route
VAGINAL
Labeler
Dispensing Solutions, Inc.
Application
NDA019964
Marketing category
NDA
Marketing start
2004-04-01
Marketing end
0000-00-00
Substance
TERCONAZOLE
Active strength
8 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
55045-3259-32019-10-29C16284748780-1960f7f55-d5f5-8e05-e053-dbdaa90a074aTERCONAZOLE VAGINAL CREAM 0.4% 7-Day Regimen TERCONAZOLE VAGINAL CREAM 0.8% 3-Day Regimen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55045-3259-3TERCONAZOLE20 g in 1 TUBE, WITH APPLICATORCREAM201

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TERCONAZOLEACTIVE INGREDIENT0KJ2VE664UTERCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]1
TERCONAZOLEACTIVE MOIETY0KJ2VE664UTERCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UTERCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNTERCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSTERCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MTERCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTERCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TERCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YTERCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTERCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55045-3259TERCONAZOLE CREAM [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 1 package rows20110930_8e125228-4963-4a7b-a0e7-857e63496486.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313227terconazole 0.8 % Vaginal CreamPSN8e125228-4963-4a7b-a0e7-857e634964861
313227terconazole 8 MG/ML Vaginal CreamSCD8e125228-4963-4a7b-a0e7-857e634964861
313227terconazole 0.8 % Vaginal CreamSY8e125228-4963-4a7b-a0e7-857e634964861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
55045-3259-35504532590320 g in 1 TUBE, WITH APPLICATOR20 gHistorical