Terconazole

Product NDC
50090-0917
11-digit product format
500900917
Labeler code
50090
Product ID
50090-0917_36d90915-c768-4dc2-ba7f-6f8fe8764e08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terconazole
Dosage form
CREAM
Route
VAGINAL
Labeler
A-S Medication Solutions
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
50090-0917-0Terconazole45 g in 1 TUBE, WITH APPLICATORCREAM4512
50090-0917-0Terconazole1 in 1 CARTONCREAM112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0917-0GM - Gram50090-09177ddcc3d0-198d-4224-8d87-9e7acfa1236312018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0917TERCONAZOLE CREAM [A-S MEDICATION SOLUTIONS]12Current NDC, Legacy NDC, 2 package rows20231210_b922feb5-cd85-4f13-9a18-913e58f8da83.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-0917-0500900917001 TUBE, WITH APPLICATOR in 1 CARTON (50090-0917-0) / 45 g in 1 TUBE, WITH APPLICATOR2014-11-280000-00-00NoNoCurrent