FDA Product

Prednisone

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

Basic Information

Product Name

Prednisone

FDA Product Code

53002-3090

Regulatory Information

NDC Product Code

53002-3090

Application Number

ANDA040362

Marketing Category

C73584

Effective Date

December 7, 2017

Territorial Authority

USA

FDA Title

PredniSONE Tablets, USP Rx only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

8

Company Information

ManufacturerRPK Pharmaceuticals, Inc.

DUNS Number

147096275

Active Ingredients

Quantity: 10 mg in 1 1

Code: VB0R961HZT

Class Code: ACTIB

Inactive Ingredients

Starch, Corn

Code: O8232NY3SJ

Class Code: IACT

Magnesium stearate

Code: 70097M6I30

Class Code: IACT

Sodium lauryl sulfate

Code: 368GB5141J

Class Code: IACT

Starch, Potato

Code: 8I089SAH3T

Class Code: IACT

Lactose monohydrate

Code: EWQ57Q8I5X

Class Code: IACT

Active Moieties

PREDNISONE

Code: VB0R961HZT

© Copyright 2025. All Rights Reserved by MedPath

Home Terms & Conditions Privacy Policy