Terconazole

Product NDC
53002-7240
11-digit product format
530027240
Labeler code
53002
Product ID
53002-7240_d6687dce-5459-463e-94cd-d26d787fa129
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Terconazole
Dosage form
CREAM
Route
VAGINAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA075953
Marketing category
ANDA
Marketing start
2004-04-06
Marketing end
0000-00-00
Substance
TERCONAZOLE
Active strength
8 mg/g
Pharmacologic classes
Azole Antifungal [EPC],Azoles [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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
53002-7240-1Terconazole1 in 1 CARTONCREAM15
53002-7240-1Terconazole20 g in 1 TUBE, WITH APPLICATORCREAM205

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-7240TERCONAZOLE CREAM [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 2 package rows20230609_c46cf36e-cf06-4a64-963c-a55bb0194f74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313227terconazole 0.8 % Vaginal CreamPSNc46cf36e-cf06-4a64-963c-a55bb0194f745
313227terconazole 8 MG/ML Vaginal CreamSCDc46cf36e-cf06-4a64-963c-a55bb0194f745
313227terconazole 0.8 % Vaginal CreamSYc46cf36e-cf06-4a64-963c-a55bb0194f745

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-7240-1530027240011 TUBE, WITH APPLICATOR in 1 CARTON (53002-7240-1) > 20 g in 1 TUBE, WITH APPLICATOR2018-10-010000-00-00NoNoCurrent