FDA Product

Prednisone

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

Basic Information

Product Name

Prednisone

FDA Product Code

55154-4310

Regulatory Information

NDC Product Code

55154-4310

Application Number

ANDA040362

Marketing Category

C73584

Effective Date

August 8, 2023

Territorial Authority

USA

FDA Title

PredniSONE Tablets, USP Rx only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerCardinal Health 107, LLC

DUNS Number

118546603

Active Ingredients

Lactose monohydrate

Code: EWQ57Q8I5X

Class Code: IACT

Sodium lauryl sulfate

Code: 368GB5141J

Class Code: IACT

Quantity: 20 mg in 1 1

Code: VB0R961HZT

Class Code: ACTIB

Magnesium stearate

Code: 70097M6I30

Class Code: IACT

Aluminum Oxide

Code: LMI26O6933

Class Code: IACT

Starch, Corn

Code: O8232NY3SJ

Class Code: IACT

Fd&c Yellow No. 6

Code: H77VEI93A8

Class Code: IACT

Starch, Potato

Code: 8I089SAH3T

Class Code: IACT

Active Moieties

Prednisone

Code: VB0R961HZT

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