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FDA Product

Depo-Medrol

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Depo-Medrol

50090-0312

Regulatory Information

50090-0312

NDA011757

C73594

March 10, 2021

USA

DEPO-MEDROL (methylprednisolone acetate injectable suspension, USP)

HUMAN PRESCRIPTION DRUG LABEL

11

Company Information

830016429

Active Ingredients

SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM

Quantity: 6.8 mg in 1 mL

Code: 3980JIH2SW

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

POLYSORBATE 80

Quantity: 1.94 mg in 1 mL

Code: 6OZP39ZG8H

Class Code: IACT

SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM

Quantity: 1.42 mg in 1 mL

Code: GR686LBA74

Class Code: IACT

BENZYL ALCOHOL

Quantity: 9.16 mg in 1 mL

Code: LKG8494WBH

Class Code: IACT

SODIUM CHLORIDE

Code: 451W47IQ8X

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

Active Moieties

METHYLPREDNISOLONE

Code: X4W7ZR7023

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