Clotrimazole

Product NDC
68071-2614
11-digit product format
680712614
Labeler code
68071
Product ID
68071-2614_d505c338-ddbf-26eb-e053-2a95a90a0261
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
VAGINAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA074165
Marketing category
ANDA
Marketing start
2021-06-29
Marketing end
0000-00-00
Substance
CLOTRIMAZOLE
Active strength
10 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2614-42025-01-30C16284748780-12cef2736-5b8e-d83d-e063-dadaa90ab31fClotrimazole

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2614-4Clotrimazole45 g in 1 TUBE, WITH APPLICATORCREAM451
68071-2614-4Clotrimazole1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2614CLOTRIMAZOLE CREAM [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 2 package rows20220217_d505c338-ddbe-26eb-e053-2a95a90a0261.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309368clotrimazole 1 % Vaginal CreamPSNd505c338-ddbe-26eb-e053-2a95a90a02611
309368clotrimazole 10 MG/ML Vaginal CreamSCDd505c338-ddbe-26eb-e053-2a95a90a02611
309368clotrimazole 1 % Vaginal CreamSYd505c338-ddbe-26eb-e053-2a95a90a02611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2614-4680712614041 TUBE, WITH APPLICATOR in 1 CARTON (68071-2614-4) > 45 g in 1 TUBE, WITH APPLICATOR2022-01-070000-00-00NoNoCurrent