FDA Product

Prednisone

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

Basic Information

Product Name

Prednisone

FDA Product Code

43063-703

Regulatory Information

NDC Product Code

43063-703

Application Number

ANDA040362

Marketing Category

C73584

Effective Date

September 19, 2023

Territorial Authority

USA

FDA Title

PredniSONE Tablets, USP Rx only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

21

Company Information

ManufacturerPD-Rx Pharmaceuticals, Inc.

DUNS Number

156893695

Active Ingredients

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

ALUMINUM OXIDE

Code: LMI26O6933

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

STARCH, POTATO

Code: 8I089SAH3T

Class Code: IACT

Quantity: 20 mg in 1 1

Code: VB0R961HZT

Class Code: ACTIB

Active Moieties

PREDNISONE

Code: VB0R961HZT

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