Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Betamethasone Dipropionate
Product Details
NDC Product Code
54868-0973Application Number
ANDA019137Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
January 3, 2012BetamethasoneActive
Code: 826Y60901UClass: ACTIMQuantity: 0.5 mg in 1 g
CHLOROCRESOLInactive
Code: 36W53O7109Class: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1SClass: IACT
CETETH-20Inactive
Code: I835H2IHHXClass: IACT
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PHOSPHORIC ACIDInactive
Code: E4GA8884NNClass: IACT
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RNClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
Betamethasone Dipropionate
Product Details
NDC Product Code
54868-3280Application Number
ANDA019141Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
January 3, 2012MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
BetamethasoneActive
Code: 826Y60901UClass: ACTIMQuantity: 0.5 mg in 1 g
PETROLATUMInactive
Code: 4T6H12BN9UClass: IACT
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
SPL UNCLASSIFIED SECTION
(Potency expressed as betamethasone)
Rx only
For Dermatologic Use Only
Not for Ophthalmic Use