Terconazole

Product NDC
50090-1196
11-digit product format
500901196
Labeler code
50090
Product ID
50090-1196_f235c1c5-0e31-43a4-abec-f622945d799e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terconazole
Dosage form
CREAM
Route
VAGINAL
Labeler
A-S Medication Solutions
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1196-0Terconazole20 g in 1 TUBE, WITH APPLICATORCREAM2014
50090-1196-0Terconazole1 in 1 CARTONCREAM114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1196-0GM - Gram50090-119676b5f9d0-f2b7-46d5-b2bd-f6ea9f53a84312018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1196TERCONAZOLE CREAM [A-S MEDICATION SOLUTIONS]14Current NDC, Legacy NDC, 2 package rows20230105_1e32bf0d-2a93-44ac-ae28-8d34e10380c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313227terconazole 0.8 % Vaginal CreamPSN1e32bf0d-2a93-44ac-ae28-8d34e10380c014
313227terconazole 8 MG/ML Vaginal CreamSCD1e32bf0d-2a93-44ac-ae28-8d34e10380c014
313227terconazole 0.8 % Vaginal CreamSY1e32bf0d-2a93-44ac-ae28-8d34e10380c014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1196-0500901196001 TUBE, WITH APPLICATOR in 1 CARTON (50090-1196-0) / 20 g in 1 TUBE, WITH APPLICATOR2014-11-280000-00-00NoNoCurrent