FDA.reportPublic FDA data

Clotrimazole and Betamethasone Dipropionate

Product NDC
50436-4546
11-digit product format
504364546
Labeler code
50436
Product ID
50436-4546_b8656e41-ef9e-4571-8da3-6bcf44b965f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clotrimazole and Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Unit Dose Services
Application
ANDA075502
Marketing category
ANDA
Marketing start
2001-06-05
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
2020-12-31
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
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
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
50436-4546-12021-01-29C16284748780-1ba0f9c33-40e9-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base) safely and effectively. See full prescribing information for CLOTRIMAZOLE and BETAMETHASONE DIPROPIONATE CREAM, 1%/0.05% (base). CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE cream, 1%/0.05% (base) for topical use Initial U.S. Approval: 1984

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-4546-1Clotrimazole and Betamethasone Dipropionate15 g in 1 TUBECREAM154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-4546-1GM - Gram50436-45468b986264-8ba0-482d-b3b1-8d61bbcbfeb612017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-4546CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [UNIT DOSE SERVICES]4Legacy NDC, 1 package rows20170702_38ac6015-3823-48a2-a02c-433ccaeaf785.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSN38ac6015-3823-48a2-a02c-433ccaeaf7854
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCD38ac6015-3823-48a2-a02c-433ccaeaf7854
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSY38ac6015-3823-48a2-a02c-433ccaeaf7854
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSY38ac6015-3823-48a2-a02c-433ccaeaf7854

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50436-4546-15043645460115 g in 1 TUBE15 gHistorical