FDA.reportPublic FDA data

Terconazole

Product NDC
51672-1302
11-digit product format
516721302
Labeler code
51672
Product ID
51672-1302_395de373-caf5-13e9-e063-6294a90a5684
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terconazole
Dosage form
CREAM
Route
VAGINAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA075953
Marketing category
ANDA
Marketing start
2004-04-06
Substance
TERCONAZOLE
Active strength
8 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Terconazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERCONAZOLE8 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0KJ2VE664U
Rxcui313227

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a1f2acc3-46a1-8c88-4468-5826c2e9fea6Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1302-0Terconazole1 in 1 CARTONCREAM110
51672-1302-0Terconazole20 g in 1 TUBE, WITH APPLICATORCREAM2010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1302-0GM - Gram51672-13020e9905d3-1c55-4bea-9c9d-23e7ea22846612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TerconazoleACTIVE INGREDIENT0KJ2VE664UTERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4
TerconazoleACTIVE MOIETY0KJ2VE664UTERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4
butylated hydroxyanisoleINACTIVE INGREDIENTREK4960K2UTERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4
cetyl alcoholINACTIVE INGREDIENT936JST6JCNTERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSTERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4
polysorbate 60INACTIVE INGREDIENTCAL22UVI4MTERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HTERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YTERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4
waterINACTIVE INGREDIENT059QF0KO0RTERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4
TERCONAZOLEACTIVE INGREDIENT0KJ2VE664UTERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
TERCONAZOLEACTIVE MOIETY0KJ2VE664UTERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UTERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNTERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSTERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MTERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YTERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTERCONAZOLE CREAM [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1302TERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]9Current NDC, Legacy NDC, 2 package rows20241222_6d7a8fd6-7837-427e-9b18-89e33351b05e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313227terconazole 0.8 % Vaginal CreamPSN1e32bf0d-2a93-44ac-ae28-8d34e10380c014
313227terconazole 8 MG/ML Vaginal CreamSCD1e32bf0d-2a93-44ac-ae28-8d34e10380c014
313227terconazole 0.8 % Vaginal CreamSY1e32bf0d-2a93-44ac-ae28-8d34e10380c014
313227terconazole 0.8 % Vaginal CreamPSN6d7a8fd6-7837-427e-9b18-89e33351b05e10
313227terconazole 8 MG/ML Vaginal CreamSCD6d7a8fd6-7837-427e-9b18-89e33351b05e10
313227terconazole 0.8 % Vaginal CreamSY6d7a8fd6-7837-427e-9b18-89e33351b05e10
313227terconazole 0.8 % Vaginal CreamPSN71c13149-396e-edc6-e053-2a95a90af50c6
313227terconazole 8 MG/ML Vaginal CreamSCD71c13149-396e-edc6-e053-2a95a90af50c6
313227terconazole 0.8 % Vaginal CreamSY71c13149-396e-edc6-e053-2a95a90af50c6
313227terconazole 0.8 % Vaginal CreamPSNc46cf36e-cf06-4a64-963c-a55bb0194f745
313227terconazole 8 MG/ML Vaginal CreamSCDc46cf36e-cf06-4a64-963c-a55bb0194f745
313227terconazole 0.8 % Vaginal CreamSYc46cf36e-cf06-4a64-963c-a55bb0194f745

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51672-1302-0516721302001 TUBE, WITH APPLICATOR in 1 CARTON (51672-1302-0) / 20 g in 1 TUBE, WITH APPLICATOR2004-04-060000-00-00NoNoCurrent