FDA.reportPublic FDA data

Clotrimazole and Betamethasone Dipropionate

Product NDC
0168-0258
11-digit product format
001680258
Labeler code
0168
Product ID
0168-0258_e327c963-4ef7-4521-8a53-0c249cd21857
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clotrimazole and Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Application
ANDA075502
Marketing category
ANDA
Marketing start
2001-06-05
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clotrimazole and Betamethasone Dipropionate
Listing expiration
2027-12-31

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
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
0168-0258-152025-07-29C16284748780-1ab0e2407-3626-f274-e053-dbdaa90a6471These 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
0168-0258-462025-07-29C16284748780-1ab0e2407-3626-f274-e053-dbdaa90a6471These 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
0168-0258-152020-09-17C16284748780-1ab0e2407-3626-f274-e053-dbdaa90a6471These 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
0168-0258-462020-09-17C16284748780-1ab0e2407-3626-f274-e053-dbdaa90a6471These 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
0168-0258-152020-07-22C16284748780-1ab0e2407-3626-f274-e053-dbdaa90a6471These 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
0168-0258-462020-07-22C16284748780-1ab0e2407-3626-f274-e053-dbdaa90a6471These 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
0168-0258-15Clotrimazole and Betamethasone Dipropionate15 g in 1 TUBECREAM1514
0168-0258-46Clotrimazole and Betamethasone Dipropionate45 g in 1 TUBECREAM4514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0258-15GM - Gram0168-02586bca82ca-e8b1-4f8d-baba-fe20d61a962012012-07-24
0168-0258-46GM - Gram0168-0258bc352828-349e-4f05-86c3-780d0ccfa98312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAMETHASONE DIPROPIONATEACTIVE INGREDIENT826Y60901UCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9
clotrimazoleACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9
BETAMETHASONEACTIVE MOIETY9842X06Q6MCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9
clotrimazoleACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9
CETEARETH-30INACTIVE INGREDIENT1R9DCZ5FOXCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9
WATERINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0168-0258CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 2 package rows20200918_55db730a-df6d-4950-9c26-91b06bdcef36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSN55db730a-df6d-4950-9c26-91b06bdcef3614
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCD55db730a-df6d-4950-9c26-91b06bdcef3614
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSY55db730a-df6d-4950-9c26-91b06bdcef3614
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSY55db730a-df6d-4950-9c26-91b06bdcef3614
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
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSN0d675012-0e22-4cfe-8b33-a1f39c57e04d3
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCD0d675012-0e22-4cfe-8b33-a1f39c57e04d3
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSY0d675012-0e22-4cfe-8b33-a1f39c57e04d3
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSY0d675012-0e22-4cfe-8b33-a1f39c57e04d3
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSNf82ff62b-96a1-4b9c-80f6-c17192f6bbd02
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCDf82ff62b-96a1-4b9c-80f6-c17192f6bbd02
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSYf82ff62b-96a1-4b9c-80f6-c17192f6bbd02
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSYf82ff62b-96a1-4b9c-80f6-c17192f6bbd02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0168-0258-150016802581515 g in 1 TUBE (0168-0258-15) 15 g2001-06-050000-00-00NoNoCurrent
0168-0258-460016802584645 g in 1 TUBE (0168-0258-46) 45 g2001-06-050000-00-00NoNoCurrent