FDA Product

methylprednisolone

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

Basic Information

Product Name

methylprednisolone

FDA Product Code

68382-917

Regulatory Information

NDC Product Code

68382-917

Application Number

ANDA206751

Marketing Category

C73584

Effective Date

December 27, 2023

Territorial Authority

USA

FDA Title

METHYLPREDNISOLONE TABLETS, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

6

Company Information

ManufacturerZydus Pharmaceuticals USA Inc.

DUNS Number

156861945

Active Ingredients

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

METHYLPREDNISOLONE

Quantity: 8 mg in 1 1

Code: X4W7ZR7023

Class Code: ACTIB

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

Active Moieties

METHYLPREDNISOLONE

Code: X4W7ZR7023

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