Betamethasone Sodium Phosphate and Betamethasone Acetate
Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension, USP
Approved
Approval ID
335f17e7-069d-456c-8507-26253692f2ee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 19, 2019
Manufacturers
FDA
American Regent, Inc.
DUNS: 002033710
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Betamethasone Sodium Phosphate and Betamethasone Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0517-0791
Application NumberANDA090747
Product Classification
M
Marketing Category
C73584
G
Generic Name
Betamethasone Sodium Phosphate and Betamethasone Acetate
Product Specifications
Route of AdministrationINTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR
Effective DateAugust 19, 2019
FDA Product Classification
INGREDIENTS (7)
BETAMETHASONE ACETATEActive
Quantity: 3 mg in 1 mL
Code: TI05AO53L7
Classification: ACTIB
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 7.1 mg in 1 mL
Code: 22ADO53M6F
Classification: IACT
BETAMETHASONE SODIUM PHOSPHATEActive
Quantity: 3 mg in 1 mL
Code: 7BK02SCL3W
Classification: ACTIM
EDETATE DISODIUMInactive
Quantity: 0.1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 3.4 mg in 1 mL
Code: 593YOG76RN
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Quantity: 0.2 mg in 1 mL
Code: F5UM2KM3W7
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT