Terconazole

Product NDC
0713-0552
11-digit product format
007130552
Labeler code
0713
Product ID
0713-0552_ee20ae91-d9b6-6f7f-e053-2a95a90a3171
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terconazole
Dosage form
SUPPOSITORY
Route
VAGINAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA077553
Marketing category
ANDA
Marketing start
2015-09-25
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TERCONAZOLE80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0KJ2VE664U

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
0713-0552-73Terconazole3 in 1 CARTONSUPPOSITORY33
0713-0552-73Terconazole1 in 1 BLISTER PACKSUPPOSITORY13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0552-73EA - Each0713-0552ee65327c-6294-4e49-863a-19dbcd19f8a512015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TerconazoleACTIVE INGREDIENT0KJ2VE664UTERCONAZOLE SUPPOSITORY [G & W LABORATORIES, INC.]1
TerconazoleACTIVE MOIETY0KJ2VE664UTERCONAZOLE SUPPOSITORY [G & W LABORATORIES, INC.]1
butylated hydroxyanisoleINACTIVE INGREDIENTREK4960K2UTERCONAZOLE SUPPOSITORY [G & W LABORATORIES, INC.]1
coconut oilINACTIVE INGREDIENTQ9L0O73W7LTERCONAZOLE SUPPOSITORY [G & W LABORATORIES, INC.]1
palm kernel oilINACTIVE INGREDIENTB0S90M0233TERCONAZOLE SUPPOSITORY [G & W LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0552TERCONAZOLE SUPPOSITORY [COSETTE PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20221124_38cd1718-6b3c-415d-a17f-7b399adb0ba2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198245terconazole 80 MG Vaginal InsertPSN38cd1718-6b3c-415d-a17f-7b399adb0ba23
198245terconazole 80 MG Vaginal InsertSCD38cd1718-6b3c-415d-a17f-7b399adb0ba23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0552-73007130552733 BLISTER PACK in 1 CARTON (0713-0552-73) / 1 SUPPOSITORY in 1 BLISTER PACK3 blister pack2015-09-250000-00-00NoNoCurrent