FDA.reportPublic FDA data

Clotrimazole and Betamethasone Dipropionate

Product NDC
53002-9741
11-digit product format
530029741
Labeler code
53002
Product ID
53002-9741_ec1a80e6-960d-42f8-acc4-c9a57a59cf87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clotrimazole and Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA076002
Marketing category
ANDA
Marketing start
2003-12-16
Marketing end
0000-00-00
Substance
CLOTRIMAZOLE; BETAMETHASONE DIPROPIONATE
Active strength
10 mg/g; mg/g
Pharmacologic classes
Azole Antifungal [EPC],Azoles [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
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
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
dde7b902-54a1-627e-12f1-9e6d244ab88cProduct name420250317
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
0a2fcc35-464b-9ec2-a622-753662cdd48cProduct name320240216
6f762601-17ef-4321-8f47-77783d3c4d8bProduct name320231116
1dbefad7-ab34-69c3-e51a-e7148aa38f70Product name520220921
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
4ea9e4b5-b452-48ad-9b25-b9a4d403405dProduct name120160310
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
4f07db9b-3707-3e2c-05b5-d7852ba808c4Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-9741-12023-01-30C16284748780-1f386c649-c442-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM safely and effectively. See full prescribing information for CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM. CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE cream, for topical use Initial U.S. Approval: 1984

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-9741-1Clotrimazole and Betamethasone Dipropionate15 g in 1 TUBECREAM151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-9741CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20200218_1f6b6287-6b86-45f5-a56b-93204a67e2f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSN1f6b6287-6b86-45f5-a56b-93204a67e2f51
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCD1f6b6287-6b86-45f5-a56b-93204a67e2f51
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSY1f6b6287-6b86-45f5-a56b-93204a67e2f51
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSY1f6b6287-6b86-45f5-a56b-93204a67e2f51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-9741-15300297410115 g in 1 TUBE (53002-9741-1) 15 g2018-10-010000-00-00NoNoCurrent