FDA.reportPublic FDA data

Clotrimazole and Betamethasone Dipropionate

Product NDC
80425-0344
11-digit product format
804250344
Labeler code
80425
Product ID
80425-0344_2a9bfe6a-6d75-b262-e063-6294a90a1cf3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clotrimazole and Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA075673
Marketing category
ANDA
Marketing start
2023-06-15
Substance
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
Active strength
.5; 10 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clotrimazole and Betamethasone Dipropionate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETAMETHASONE DIPROPIONATE.5 mg/g
CLOTRIMAZOLE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii826Y60901U, G07GZ97H65
Rxcui308714

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0344-1Clotrimazole and Betamethasone Dipropionate1 in 1 CARTONCREAM12
80425-0344-1Clotrimazole and Betamethasone Dipropionate15 g in 1 TUBECREAM152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0344-1GM - Gram80425-0344a79c20cd-f149-4609-9af4-268e6954d9b512023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0344CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 2 package rows20250102_fe2ec7d2-23c2-e99f-e053-6294a90aa65a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSNfe2ec7d2-23c2-e99f-e053-6294a90aa65a2
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCDfe2ec7d2-23c2-e99f-e053-6294a90aa65a2
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSYfe2ec7d2-23c2-e99f-e053-6294a90aa65a2
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSYfe2ec7d2-23c2-e99f-e053-6294a90aa65a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0344-1804250344011 TUBE in 1 CARTON (80425-0344-1) / 15 g in 1 TUBE1 tube2023-06-15NoNoCurrent