METHYLPREDNISOLONE ACETATE

Basic Information

Product Name

FDA Product Code

0781-3522

Regulatory Information

NDC Product Code

0781-3522

Application Number

ANDA214870

Marketing Category

C73584

Effective Date

March 14, 2024

Territorial Authority

USA

FDA Title

Methylprednisolone Acetate Injectable Suspension, USP

Labeling Type

Human Prescription Drug Label

Version Number

Active Ingredients

POLYSORBATE 80

Quantity: 1.94 mg in 1 mL

Code: 6OZP39ZG8H

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

METHYLPREDNISOLONE ACETATE

Quantity: 40 mg in 1 mL

Code: 43502P7F0P

Class Code: ACTIB

POLYETHYLENE GLYCOL 3350

Quantity: 29.1 mg in 1 mL

Code: G2M7P15E5P

Class Code: IACT

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Quantity: 6.8 mg in 1 mL

Code: 593YOG76RN

Class Code: IACT

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

Quantity: 1.42 mg in 1 mL

Code: 22ADO53M6F

Class Code: IACT

BENZYL ALCOHOL

Quantity: 9.16 mg in 1 mL

Code: LKG8494WBH

Class Code: IACT

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

Active Moieties