Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Rebel Distributors Corp
Rebel Distributors Corp
118802834
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
21695-333Application Number
ANDA075673Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
December 18, 2008CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
ClotrimazoleActive
Code: G07GZ97H65Class: ACTIBQuantity: 10 mg in 1 g
BetamethasoneActive
Code: 826Y60901UClass: ACTIBQuantity: 0.64 mg in 1 g
CETEARETH-30Inactive
Code: 1R9DCZ5FOXClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
sodium phosphate, monobasicInactive
Code: 3980JIH2SWClass: IACT
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
phosphoric acidInactive
Code: E4GA8884NNClass: IACT
propylene glycolInactive
Code: 6DC9Q167V3Class: IACT
benzyl alcoholInactive
Code: LKG8494WBHClass: IACT