Betamethasone Dipropionate
These highlights do not include all the information needed to use Augmented Betamethasone Dipropionate Ointment safely and effectively. See full prescribing information for Augmented Betamethasone Dipropionate Ointment. Augmented Betamethasone Dipropionate ointment, for topical useInitial U.S. Approval: 1983
Approved
Approval ID
f5b50c00-cc6f-4296-a9ae-b16888cef4dd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2023
Manufacturers
FDA
Prasco Laboratories
DUNS: 065969375
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 Code66993-897
Application NumberNDA018741
Product Classification
M
Marketing Category
C73605
G
Generic Name
betamethasone dipropionate
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 1, 2021
FDA Product Classification
INGREDIENTS (5)
betamethasone dipropionateActive
Quantity: 0.5 mg in 1 g
Code: 826Y60901U
Classification: ACTIM
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
propylene glycol monopalmitostearateInactive
Code: F76354LMGR
Classification: IACT
white waxInactive
Code: 7G1J5DA97F
Classification: IACT
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT