Methylprednisolone Acetate
NOT FOR USE IN NEONATESCONTAINS BENZYL ALCOHOL Not for Intravenous Use
Approved
Approval ID
631f7d3e-5620-4be3-b918-2f0d38a97890
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 3, 2023
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 3
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 Code42023-239
Application NumberANDA214297
Product Classification
M
Marketing Category
C73584
G
Generic Name
METHYLPREDNISOLONE ACETATE
Product Specifications
Route of AdministrationINTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, SOFT TISSUE
Effective DateNovember 3, 2023
FDA Product Classification
INGREDIENTS (9)
METHYLPREDNISOLONE ACETATEActive
Quantity: 40 mg in 1 mL
Code: 43502P7F0P
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASICInactive
Quantity: 6.8 mg in 1 mL
Code: 3980JIH2SW
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Quantity: 1.42 mg in 1 mL
Code: GR686LBA74
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 9.16 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Quantity: 29.1 mg in 1 mL
Code: G2M7P15E5P
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 1.94 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Methylprednisolone Acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42023-240
Application NumberANDA214297
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylprednisolone Acetate
Product Specifications
Route of AdministrationINTRA-ARTERIAL, INTRALESIONAL, INTRAMUSCULAR, SOFT TISSUE
Effective DateNovember 3, 2023
FDA Product Classification
INGREDIENTS (9)
POLYSORBATE 80Inactive
Quantity: 1.88 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Quantity: 28.2 mg in 1 mL
Code: G2M7P15E5P
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Quantity: 1.37 mg in 1 mL
Code: GR686LBA74
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Quantity: 6.59 mg in 1 mL
Code: 3980JIH2SW
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
METHYLPREDNISOLONE ACETATEActive
Quantity: 80 mg in 1 mL
Code: 43502P7F0P
Classification: ACTIB
BENZYL ALCOHOLInactive
Quantity: 8.88 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
METHYLPREDNISOLONE ACETATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42023-238
Application NumberANDA214297
Product Classification
M
Marketing Category
C73584
G
Generic Name
METHYLPREDNISOLONE ACETATE
Product Specifications
Route of AdministrationINTRA-ARTICULAR, INTRALESIONAL, INTRAMENINGEAL, SOFT TISSUE
Effective DateNovember 3, 2023
FDA Product Classification
INGREDIENTS (1)
METHYLPREDNISOLONE ACETATEActive
Quantity: 40 mg in 1 mL
Code: 43502P7F0P
Classification: ACTIB