FDA Product

Prednisone

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

Basic Information

Product Name

Prednisone

FDA Product Code

63187-066

Regulatory Information

NDC Product Code

63187-066

Application Number

ANDA040256

Marketing Category

C73584

Effective Date

May 1, 2021

Territorial Authority

USA

FDA Title

PredniSONE TABLETS, USP 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

9

Company Information

ManufacturerProficient Rx LP

DUNS Number

079196022

Active Ingredients

Quantity: 5 mg in 1 1

Code: VB0R961HZT

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

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

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

Active Moieties

PREDNISONE

Code: VB0R961HZT

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