Terconazole

Product NDC
68071-1626
11-digit product format
680711626
Labeler code
68071
Product ID
68071-1626_2a0a39a9-3e19-1ddb-e063-6394a90a9d78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terconazole
Dosage form
CREAM
Route
VAGINAL
Labeler
NuCare Pharmaceuticals,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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1626-2Terconazole20 g in 1 BOXCREAM206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1626TERCONAZOLE CREAM [NUCARE PHARMACEUTICALS,INC.]6Current NDC, Legacy NDC, 1 package rows20241226_71c13149-396e-edc6-e053-2a95a90af50c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-1626-26807116260220 g in 1 BOX (68071-1626-2) 20 g2018-07-240000-00-00NoNoCurrent