FDA Product

Prednisone

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

Basic Information

Product Name

Prednisone

FDA Product Code

10544-509

Regulatory Information

NDC Product Code

10544-509

Application Number

ANDA083677

Marketing Category

C73584

Effective Date

May 23, 2013

Territorial Authority

USA

FDA Title

Prednisone Tablets, USPRev. 11/10

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerBlenheim Pharmacal, Inc.

DUNS Number

171434587

Active Ingredients

Quantity: 20 mg in 1 1

Code: VB0R961HZT

Class Code: ACTIB

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

Active Moieties

PREDNISONE

Code: VB0R961HZT

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