FDA Product

Solu-Medrol

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

Basic Information

Product Name

Solu-Medrol

FDA Product Code

52584-047

Regulatory Information

NDC Product Code

52584-047

Application Number

NDA011856

Marketing Category

C73594

Effective Date

December 27, 2022

Territorial Authority

USA

FDA Title

Solu-Medrol 125 mg/ml Injection, USP 2 mL Single Dose Vial

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

17

Company Information

ManufacturerGeneral Injectables & Vaccines, Inc

DUNS Number

108250663

Active Ingredients

Methylprednisolone Sodium Succinate

Quantity: 125 mg in 2 mL

Code: LEC9GKY20K

Class Code: ACTIM

Active Moieties

Methylprednisolone

Code: X4W7ZR7023

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