FDA Product

METHYLPREDNISOLONE

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

Basic Information

Product Name

METHYLPREDNISOLONE

FDA Product Code

76420-193

Regulatory Information

NDC Product Code

76420-193

Application Number

ANDA204072

Marketing Category

C73584

Effective Date

March 16, 2021

Territorial Authority

USA

FDA Title

MethylPREDNIsolone tablets, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerAsclemed USA, Inc.

DUNS Number

059888437

Active Ingredients

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

METHYLPREDNISOLONE

Quantity: 4 mg in 1 1

Code: X4W7ZR7023

Class Code: ACTIB

Active Moieties

METHYLPREDNISOLONE

Code: X4W7ZR7023

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