Rosuvastatin Calcium

Basic Information

Product Name

FDA Product Code

51407-154

Regulatory Information

NDC Product Code

51407-154

Application Number

ANDA207408

Marketing Category

C73584

Effective Date

September 21, 2023

Territorial Authority

USA

FDA Title

ROSUVASTATIN CALCIUM TABLETS. These highlights do not include all the information needed to use ROSUVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN CALCIUM TABLETS. ROSUVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 2003

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

ANHYDROUS DIBASIC CALCIUM PHOSPHATE

Code: L11K75P92J

Class Code: IACT

CROSPOVIDONE

Code: 2S7830E561

Class Code: IACT

HYPROMELLOSE 2208 (100 MPA.S)

Code: B1QE5P712K

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

TRIACETIN

Code: XHX3C3X673

Class Code: IACT

ROSUVASTATIN CALCIUM

Quantity: 10 mg in 1 1

Code: 83MVU38M7Q

Class Code: ACTIM

Active Moieties

ROSUVASTATIN

Code: 413KH5ZJ73

Basic Information

Regulatory Information

Company Information

Active Ingredients

ANHYDROUS DIBASIC CALCIUM PHOSPHATE

CROSPOVIDONE

HYPROMELLOSE 2208 (100 MPA.S)

LACTOSE MONOHYDRATE

TITANIUM DIOXIDE

MAGNESIUM STEARATE

CELLULOSE, MICROCRYSTALLINE

TRIACETIN

Active Moieties

ROSUVASTATIN