Clotrimazole and Betamethasone Dipropionate

Product NDC
53002-9740
11-digit product format
530029740
Labeler code
53002
Product ID
53002-9740_e98def49-c684-4258-8593-d86a2d46c020
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clotrimazole and Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA202894
Marketing category
ANDA
Marketing start
2015-11-06
Marketing end
0000-00-00
Substance
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
Active strength
1 mg/g; mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
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
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-9740-1Clotrimazole and Betamethasone Dipropionate15 g in 1 TUBECREAM156

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-9740CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [RPK PHARMACEUTICALS, INC.]6Legacy NDC, 1 package rows20220129_756180ee-4df5-4c02-8657-8d9882991036.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-9740-15300297400115 g in 1 TUBE (53002-9740-1) 15 g2018-10-010000-00-00NoNoCurrent