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FDA Approval

Clotrimazole and Betamethasone Dipropionate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
January 6, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Clotrimazole(10 mg in 1 g)
Betamethasone(0.64 mg in 1 g)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

NuCare Pharmaceuticals,Inc.

NuCare Pharmaceuticals,Inc.

010632300

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Clotrimazole and Betamethasone Dipropionate

Product Details

NDC Product Code
68071-2324
Application Number
ANDA075673
Marketing Category
ANDA (C73584)
Route of Administration
TOPICAL
Effective Date
January 6, 2021
CETEARETH-30Inactive
Code: 1R9DCZ5FOXClass: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVPClass: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NNClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RNClass: IACT
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
Code: G07GZ97H65Class: ACTIBQuantity: 10 mg in 1 g
Code: 826Y60901UClass: ACTIMQuantity: 0.64 mg in 1 g
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