Terconazole

Product NDC
50090-6299
11-digit product format
500906299
Labeler code
50090
Product ID
50090-6299_8878f816-8262-4172-b007-ce8e7ac089bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
terconazole
Dosage form
CREAM
Route
VAGINAL
Labeler
A-S Medication Solutions
Application
NDA021735
Marketing category
NDA
Marketing start
2005-02-01
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
Brand name suffix
Vaginal Cream 0.8%
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
50090-6299-0TerconazoleVaginal Cream 0.8%20 g in 1 TUBE, WITH APPLICATORCREAM201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6299-0GM - Gram50090-6299ff5d8533-6b79-4f78-94d2-386c8a1309bb12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6299TERCONAZOLE VAGINAL CREAM 0.8% (TERCONAZOLE) CREAM [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20230219_9b1c38ac-ebf3-471c-bcdf-1ff8ad197f91.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313227terconazole 0.8 % Vaginal CreamPSN9b1c38ac-ebf3-471c-bcdf-1ff8ad197f911
313227terconazole 8 MG/ML Vaginal CreamSCD9b1c38ac-ebf3-471c-bcdf-1ff8ad197f911
313227terconazole 0.8 % Vaginal CreamSY9b1c38ac-ebf3-471c-bcdf-1ff8ad197f911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6299-05009062990020 g in 1 TUBE, WITH APPLICATOR (50090-6299-0) 20 g2022-12-29NoNoHistorical