FDA Product

Prednisone

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

Basic Information

Product Name

Prednisone

FDA Product Code

68071-2594

Regulatory Information

NDC Product Code

68071-2594

Application Number

ANDA080356

Marketing Category

C73584

Effective Date

December 9, 2021

Territorial Authority

USA

FDA Title

Revised: October 2015

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerNuCare Pharmaceuticals,Inc.

DUNS Number

010632300

Active Ingredients

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

DOCUSATE SODIUM

Code: F05Q2T2JA0

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SODIUM BENZOATE

Code: OJ245FE5EU

Class Code: IACT

Quantity: 5 mg in 1 1

Code: VB0R961HZT

Class Code: ACTIB

CROSPOVIDONE

Code: 2S7830E561

Class Code: IACT

Active Moieties

PREDNISONE

Code: VB0R961HZT

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