Terconazole

Product NDC
51672-1330
11-digit product format
516721330
Labeler code
51672
Product ID
51672-1330_3961c135-42f6-e0a2-e063-6394a90a2e33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terconazole
Dosage form
SUPPOSITORY
Route
VAGINAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA077553
Marketing category
ANDA
Marketing start
2007-03-09
Substance
TERCONAZOLE
Active strength
80 mg/1
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
TERCONAZOLE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0KJ2VE664U
Rxcui198245

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
51672-1330-3Terconazole3 in 1 DOSE PACKSUPPOSITORY36
51672-1330-3Terconazole1 in 1 CARTONSUPPOSITORY16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TerconazoleACTIVE INGREDIENT0KJ2VE664UTERCONAZOLE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.]3
TerconazoleACTIVE MOIETY0KJ2VE664UTERCONAZOLE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.]3
butylated hydroxyanisoleINACTIVE INGREDIENTREK4960K2UTERCONAZOLE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.]3
coconut oilINACTIVE INGREDIENTQ9L0O73W7LTERCONAZOLE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.]3
palm kernel oilINACTIVE INGREDIENTB0S90M0233TERCONAZOLE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1330TERCONAZOLE SUPPOSITORY [TARO PHARMACEUTICALS U.S.A., INC.]5Current NDC, Legacy NDC, 2 package rows20241222_b4f50a11-bd39-4023-9145-2da60f6b085f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198245terconazole 80 MG Vaginal InsertPSNb4f50a11-bd39-4023-9145-2da60f6b085f6
198245terconazole 80 MG Vaginal InsertSCDb4f50a11-bd39-4023-9145-2da60f6b085f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-1330-3516721330031 DOSE PACK in 1 CARTON (51672-1330-3) / 3 SUPPOSITORY in 1 DOSE PACK1 dose pack2007-03-090000-00-00NoNoCurrent