FDA.reportPublic FDA data

Clotrimazole and Betamethasone Dipropionate

Product NDC
0472-0379
11-digit product format
004720379
Labeler code
0472
Product ID
0472-0379_6ecf0409-4072-415c-8381-658cce80bc76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clotrimazole and Betamethasone Dipropionate
Dosage form
CREAM
Route
TOPICAL
Labeler
Actavis Pharma, Inc.
Application
ANDA076002
Marketing category
ANDA
Marketing start
2003-12-16
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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
69b49899-11cf-4f7e-bd0a-7dc93b27311bProduct name320250130
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
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
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
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
0472-0379-15Clotrimazole and Betamethasone Dipropionate1 in 1 CARTONCREAM115
0472-0379-15Clotrimazole and Betamethasone Dipropionate15 g in 1 TUBECREAM1515
0472-0379-45Clotrimazole and Betamethasone Dipropionate1 in 1 CARTONCREAM115
0472-0379-45Clotrimazole and Betamethasone Dipropionate45 g in 1 TUBECREAM4515
0472-0379-15DermacinRx Therazole Pak15 g in 1 TUBECREAM15 g10 mg in 1g5
0472-0379-15DermacinRx Therazole Pak1 in 1 CARTONCREAM10 mg in 1g5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0472-0379-15GM - Gram0472-0379ecfd98e3-c2c4-4ced-b09e-e91636e3add612012-07-24
0472-0379-45GM - Gram0472-0379c59be4f7-0c6c-4bce-b96d-c9fb9876800712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BETAMETHASONE DIPROPIONATEACTIVE INGREDIENT826Y60901UCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
BETAMETHASONEACTIVE MOIETY9842X06Q6MCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
CETEARETH-30INACTIVE INGREDIENT1R9DCZ5FOXCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS MID ATLANTIC LLC]2
betamethasone dipropionateACTIVE INGREDIENT826Y60901UBETAMETHASONE CLOTRIMAZOLE CREAM [STAT RX USA]1
BETAMETHASONE DIPROPIONATEACTIVE INGREDIENT826Y60901UCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]1
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H65CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]1
clotrimazoleACTIVE INGREDIENTG07GZ97H65BETAMETHASONE CLOTRIMAZOLE CREAM [STAT RX USA]1
betamethasoneACTIVE MOIETY9842X06Q6MBETAMETHASONE CLOTRIMAZOLE CREAM [STAT RX USA]1
BETAMETHASONEACTIVE MOIETY9842X06Q6MCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]1
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H65CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]1
clotrimazoleACTIVE MOIETYG07GZ97H65BETAMETHASONE CLOTRIMAZOLE CREAM [STAT RX USA]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]1
CETEARETH-30INACTIVE INGREDIENT1R9DCZ5FOXCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]1
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEINACTIVE INGREDIENT593YOG76RNCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]1
WATERINACTIVE INGREDIENT059QF0KO0RCLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0472-0379CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE CREAM [ACTAVIS PHARMA, INC.]13Current NDC, Legacy NDC, 4 package rows20241116_a6ac4020-2c67-426a-8289-7e54ce43d0c9.zip
0472-0379DERMACINRX THERAZOLE PAK (CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, ZINC OXIDE) KIT [PURETEK CORPORATION]5Current NDC, Legacy NDC20241215_c47f8a9c-9c86-4068-814e-05ab2090d19e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSN153fed41-6662-4ca9-802f-84b44dcb65e9105
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCD153fed41-6662-4ca9-802f-84b44dcb65e9105
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSY153fed41-6662-4ca9-802f-84b44dcb65e9105
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSY153fed41-6662-4ca9-802f-84b44dcb65e9105
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSNa6ac4020-2c67-426a-8289-7e54ce43d0c915
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCDa6ac4020-2c67-426a-8289-7e54ce43d0c915
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSYa6ac4020-2c67-426a-8289-7e54ce43d0c915
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSYa6ac4020-2c67-426a-8289-7e54ce43d0c915
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSN5ca32ede-b546-4b65-90d6-c69add76052210
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCD5ca32ede-b546-4b65-90d6-c69add76052210
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSY5ca32ede-b546-4b65-90d6-c69add76052210
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSY5ca32ede-b546-4b65-90d6-c69add76052210
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSN3d235926-6f17-4aa5-be82-7f1b4357e2477
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCD3d235926-6f17-4aa5-be82-7f1b4357e2477
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSY3d235926-6f17-4aa5-be82-7f1b4357e2477
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSY3d235926-6f17-4aa5-be82-7f1b4357e2477
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSNc47f8a9c-9c86-4068-814e-05ab2090d19e5
416684zinc oxide 20 % Topical PastePSNc47f8a9c-9c86-4068-814e-05ab2090d19e5
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCDc47f8a9c-9c86-4068-814e-05ab2090d19e5
416684zinc oxide 0.2 MG/MG PasteSCDc47f8a9c-9c86-4068-814e-05ab2090d19e5
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSYc47f8a9c-9c86-4068-814e-05ab2090d19e5
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSYc47f8a9c-9c86-4068-814e-05ab2090d19e5
416684zinc oxide 20 % Topical PasteSYc47f8a9c-9c86-4068-814e-05ab2090d19e5
416684ZNO 0.2 MG/MG PasteSYc47f8a9c-9c86-4068-814e-05ab2090d19e5
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSN08901233-7d36-e5d9-e063-6394a90af33d3
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCD08901233-7d36-e5d9-e063-6394a90af33d3
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSY08901233-7d36-e5d9-e063-6394a90af33d3
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSY08901233-7d36-e5d9-e063-6394a90af33d3
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSN1f6b6287-6b86-45f5-a56b-93204a67e2f51
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSNde6a1bb4-0a69-4cdc-bc41-d8c62e4035991
308714clotrimazole 1 % / betamethasone 0.05 % Topical CreamPSNe947a6be-90ae-40d8-b9dd-afa14a66bb9d1
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCD1f6b6287-6b86-45f5-a56b-93204a67e2f51
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCDde6a1bb4-0a69-4cdc-bc41-d8c62e4035991
308714betamethasone 0.5 MG/ML / clotrimazole 10 MG/ML Topical CreamSCDe947a6be-90ae-40d8-b9dd-afa14a66bb9d1
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSY1f6b6287-6b86-45f5-a56b-93204a67e2f51
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSYde6a1bb4-0a69-4cdc-bc41-d8c62e4035991
308714betamethasone 0.05 % / clotrimazole 1 % Topical CreamSYe947a6be-90ae-40d8-b9dd-afa14a66bb9d1
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSY1f6b6287-6b86-45f5-a56b-93204a67e2f51
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSYde6a1bb4-0a69-4cdc-bc41-d8c62e4035991
308714betamethasone 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) / clotrimazole 10 MG/ML Topical CreamSYe947a6be-90ae-40d8-b9dd-afa14a66bb9d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0472-0379-15004720379151 TUBE in 1 CARTON (0472-0379-15) / 15 g in 1 TUBE1 tube2003-12-160000-00-00NoNoCurrent
0472-0379-45004720379451 TUBE in 1 CARTON (0472-0379-45) / 45 g in 1 TUBE1 tube2003-12-160000-00-00NoNoCurrent