FDA.reportPublic FDA data

Terconazole

Product NDC
51672-1304
11-digit product format
516721304
Labeler code
51672
Product ID
51672-1304_362a84ff-741f-ed45-e063-6394a90a54e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terconazole
Dosage form
CREAM
Route
VAGINAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA076043
Marketing category
ANDA
Marketing start
2005-01-19
Substance
TERCONAZOLE
Active strength
4 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
TERCONAZOLE4 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0KJ2VE664U
Rxcui313226

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
51672-1304-6Terconazole1 in 1 CARTONCREAM110
51672-1304-6Terconazole45 g in 1 TUBE, WITH APPLICATORCREAM4510

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1304-6GM - Gram51672-13043068858f-1322-4c18-8d7f-df11120718b112012-07-24

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 [REBEL DISTRIBUTORS CORP]1
TerconazoleACTIVE MOIETY0KJ2VE664UTERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
butylated hydroxyanisoleINACTIVE INGREDIENTREK4960K2UTERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNTERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
isopropyl myristateINACTIVE INGREDIENT0RE8K4LNJSTERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MTERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YTERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RTERCONAZOLE CREAM [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1304TERCONAZOLE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]8Current NDC, Legacy NDC, 2 package rows20241222_2b3923b5-0a97-428c-b8d2-4a3ceb3447a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313226terconazole 0.4 % Vaginal CreamPSNb922feb5-cd85-4f13-9a18-913e58f8da8312
313226terconazole 4 MG/ML Vaginal CreamSCDb922feb5-cd85-4f13-9a18-913e58f8da8312
313226terconazole 0.4 % Vaginal CreamSYb922feb5-cd85-4f13-9a18-913e58f8da8312
313226terconazole 0.4 % Vaginal CreamPSN2b3923b5-0a97-428c-b8d2-4a3ceb3447a110
313226terconazole 4 MG/ML Vaginal CreamSCD2b3923b5-0a97-428c-b8d2-4a3ceb3447a110
313226terconazole 0.4 % Vaginal CreamSY2b3923b5-0a97-428c-b8d2-4a3ceb3447a110
313226terconazole 0.4 % Vaginal CreamPSN77271d50-de82-4345-a003-e383e8e6576b5
313226terconazole 4 MG/ML Vaginal CreamSCD77271d50-de82-4345-a003-e383e8e6576b5
313226terconazole 0.4 % Vaginal CreamSY77271d50-de82-4345-a003-e383e8e6576b5
313226terconazole 0.4 % Vaginal CreamPSN5527cd23-567b-4019-8e5c-f71ee7ed26891
313226terconazole 4 MG/ML Vaginal CreamSCD5527cd23-567b-4019-8e5c-f71ee7ed26891
313226terconazole 0.4 % Vaginal CreamSY5527cd23-567b-4019-8e5c-f71ee7ed26891

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51672-1304-6516721304061 TUBE, WITH APPLICATOR in 1 CARTON (51672-1304-6) / 45 g in 1 TUBE, WITH APPLICATOR2005-01-190000-00-00NoNoCurrent