Betamethasone Dipropionate
BETAMETHASONE DIPROPIONATE CREAM, USP 0.05%(Potency expressed as betamethasone) FOR DERMATOLOGIC USE ONLYNOT FOR OPHTHALMIC USE Rx only
Approved
Approval ID
d5815efe-f29c-4356-9f2e-3ec6fcd477bc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2021
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Betamethasone Dipropionate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-5260
Application NumberANDA210217
Product Classification
M
Marketing Category
C73584
G
Generic Name
Betamethasone Dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 18, 2018
FDA Product Classification
INGREDIENTS (11)
BETAMETHASONE DIPROPIONATEActive
Quantity: 0.5 mg in 1 g
Code: 826Y60901U
Classification: ACTIM
PetrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Mineral OilInactive
Code: T5L8T28FGP
Classification: IACT
Polyoxyl 20 Cetostearyl EtherInactive
Code: YRC528SWUY
Classification: IACT
Stearyl AlcoholInactive
Code: 2KR89I4H1Y
Classification: IACT
Cetyl AlcoholInactive
Code: 936JST6JCN
Classification: IACT
ChlorocresolInactive
Code: 36W53O7109
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Phosphoric AcidInactive
Code: E4GA8884NN
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT