Methylprednisolone Acetate
MethylPREDNISolone Acetate Injectable Suspension, USP
Approved
Approval ID
faf608f3-a13d-4969-b1a6-bb0bc1de2a8e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methylprednisolone Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-850
Application NumberANDA040794
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylprednisolone Acetate
Product Specifications
Route of AdministrationINTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, PARENTERAL, SOFT TISSUE
Effective DateJuly 27, 2009
FDA Product Classification
INGREDIENTS (5)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
METHYLPREDNISOLONE ACETATEActive
Quantity: 80 mg in 1 mL
Code: 43502P7F0P
Classification: ACTIB
POLYETHYLENE GLYCOL 3350Inactive
Quantity: 28 mg in 1 mL
Code: G2M7P15E5P
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
Methylprednisolone Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-849
Application NumberANDA040794
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylprednisolone Acetate
Product Specifications
Route of AdministrationINTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, PARENTERAL, SOFT TISSUE
Effective DateJuly 27, 2009
FDA Product Classification
INGREDIENTS (5)
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
METHYLPREDNISOLONE ACETATEActive
Quantity: 40 mg in 1 mL
Code: 43502P7F0P
Classification: ACTIB
POLYETHYLENE GLYCOL 3350Inactive
Quantity: 29 mg in 1 mL
Code: G2M7P15E5P
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT