Clotrimazole and Betamethasone Dipropionate

Product NDC
68462-298
11-digit product format
684620298
Labeler code
68462
Product ID
68462-298_2fc6dcb9-879f-4d6e-8194-4a30af922986
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clotrimazole and Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Glenmark Pharmaceuticals Inc. USA
Application
ANDA202894
Marketing category
ANDA
Marketing start
2015-11-06
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-298-17Clotrimazole and Betamethasone Dipropionate15 g in 1 TUBECREAM155
68462-298-55Clotrimazole and Betamethasone Dipropionate45 g in 1 TUBECREAM455

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-298-17GM - Gram68462-298e7d77887-7d72-47bb-81a1-3c254cad850912015-12-02
68462-298-55GM - Gram68462-298bce53ca3-855c-4618-80fe-52f005a1ad8112015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAMETHASONE DIPROPIONATEACTIVE INGREDIENT826Y60901UCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]1
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]1
BETAMETHASONEACTIVE MOIETY9842X06Q6MCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]1
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]1
CETEARETH-30INACTIVE INGREDIENT1R9DCZ5FOXCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]1
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]1
WATERINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-298CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [GLENMARK PHARMACEUTICALS INC. USA]5Current NDC, Legacy NDC, 2 package rows20240104_8dcd24cb-e568-428a-88ac-737d115cc54d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSN8dcd24cb-e568-428a-88ac-737d115cc54d5
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSN5cc511e4-3e7d-70d6-e053-2a91aa0a80445
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCD8dcd24cb-e568-428a-88ac-737d115cc54d5
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCD5cc511e4-3e7d-70d6-e053-2a91aa0a80445
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSY8dcd24cb-e568-428a-88ac-737d115cc54d5
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSY5cc511e4-3e7d-70d6-e053-2a91aa0a80445
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSY8dcd24cb-e568-428a-88ac-737d115cc54d5
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSY5cc511e4-3e7d-70d6-e053-2a91aa0a80445
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSN119377f2-dca4-42e4-acf7-6ff56916696a3
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCD119377f2-dca4-42e4-acf7-6ff56916696a3
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSY119377f2-dca4-42e4-acf7-6ff56916696a3
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSY119377f2-dca4-42e4-acf7-6ff56916696a3
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSNbbf26437-c9b4-d8e6-e053-2a95a90a00622
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCDbbf26437-c9b4-d8e6-e053-2a95a90a00622
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSYbbf26437-c9b4-d8e6-e053-2a95a90a00622
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSYbbf26437-c9b4-d8e6-e053-2a95a90a00622
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSN239fa275-373a-2a59-e063-6394a90afdcb1
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSNc6e4bf5f-f6d6-489e-9286-c30568c601b71
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCD239fa275-373a-2a59-e063-6394a90afdcb1
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCDc6e4bf5f-f6d6-489e-9286-c30568c601b71
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSY239fa275-373a-2a59-e063-6394a90afdcb1
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSYc6e4bf5f-f6d6-489e-9286-c30568c601b71
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSY239fa275-373a-2a59-e063-6394a90afdcb1
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSYc6e4bf5f-f6d6-489e-9286-c30568c601b71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-298-176846202981715 g in 1 TUBE (68462-298-17) 15 g2015-11-060000-00-00NoNoCurrent
68462-298-556846202985545 g in 1 TUBE (68462-298-55) 45 g2015-11-060000-00-00NoNoCurrent