FDA.reportPublic FDA data

CRESTOR

Product NDC
43353-031
11-digit product format
433530031
Labeler code
43353
Product ID
43353-031_0291bd29-faa4-4aa9-83f6-7cb28c229413
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA021366
Marketing category
NDA
Marketing start
2003-08-18
Marketing end
0000-00-00
Substance
ROSUVASTATIN CALCIUM
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-031-152020-01-31C16284748780-19d75b9d0-d2ac-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CRESTOR safely and effectively. See full prescribing information for CRESTOR. CRESTOR (rosuvastatin calcium) tablets Initial U.S. Approval: 2003
43353-031-452020-01-31C16284748780-19d75b9d0-d2ac-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CRESTOR safely and effectively. See full prescribing information for CRESTOR. CRESTOR (rosuvastatin calcium) tablets Initial U.S. Approval: 2003
43353-031-602020-01-31C16284748780-19d75b9d0-d2ac-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CRESTOR safely and effectively. See full prescribing information for CRESTOR. CRESTOR (rosuvastatin calcium) tablets Initial U.S. Approval: 2003
43353-031-822020-01-31C16284748780-19d75b9d0-d2ac-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CRESTOR safely and effectively. See full prescribing information for CRESTOR. CRESTOR (rosuvastatin calcium) tablets Initial U.S. Approval: 2003
43353-031-912020-01-31C16284748780-19d75b9d0-d2ac-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CRESTOR safely and effectively. See full prescribing information for CRESTOR. CRESTOR (rosuvastatin calcium) tablets Initial U.S. Approval: 2003
43353-031-992020-01-31C16284748780-19d75b9d0-d2ac-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use CRESTOR safely and effectively. See full prescribing information for CRESTOR. CRESTOR (rosuvastatin calcium) tablets Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-031-15CRESTOR15 in 1 BOTTLE, PLASTICTABLET, FILM COATED152
43353-031-45CRESTOR45 in 1 BOTTLE, PLASTICTABLET, FILM COATED452
43353-031-60CRESTOR90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902
43353-031-82CRESTOR1200 in 1 BOTTLE, PLASTICTABLET, FILM COATED12002
43353-031-91CRESTOR1260 in 1 BOTTLE, PLASTICTABLET, FILM COATED12602
43353-031-99CRESTOR600 in 1 BOTTLE, PLASTICTABLET, FILM COATED6002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-031-15EA - Each43353-0312e176490-2d21-44ce-a287-1653aa25594e12014-05-02
43353-031-45EA - Each43353-031a6687bee-b7cf-45d9-ae91-604c588012eb12014-05-02
43353-031-60EA - Each43353-0319679e910-48b7-4a83-a102-cdb5c584317712014-05-02
43353-031-82EA - Each43353-031f61a9953-2089-4a38-a2fb-928051ac780312014-05-02
43353-031-91EA - Each43353-031f4500624-df81-4b39-991f-15ffa60e4edb12014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROSUVASTATIN CALCIUMACTIVE INGREDIENT83MVU38M7QCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
ROSUVASTATINACTIVE MOIETY413KH5ZJ73CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TRIACETININACTIVE INGREDIENTXHX3C3X673CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-031CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 6 package rows20140410_3ec57aa3-4399-46c9-9292-567d2a09df4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859749CRESTOR 10 MG Oral TabletPSN3ec57aa3-4399-46c9-9292-567d2a09df4f2
859753CRESTOR 20 MG Oral TabletPSN3ec57aa3-4399-46c9-9292-567d2a09df4f2
859421CRESTOR 40 MG Oral TabletPSN3ec57aa3-4399-46c9-9292-567d2a09df4f2
859747rosuvastatin calcium 10 MG Oral TabletPSN3ec57aa3-4399-46c9-9292-567d2a09df4f2
859751rosuvastatin calcium 20 MG Oral TabletPSN3ec57aa3-4399-46c9-9292-567d2a09df4f2
859419rosuvastatin calcium 40 MG Oral TabletPSN3ec57aa3-4399-46c9-9292-567d2a09df4f2
859749rosuvastatin calcium 10 MG Oral Tablet [Crestor]SBD3ec57aa3-4399-46c9-9292-567d2a09df4f2
859753rosuvastatin calcium 20 MG Oral Tablet [Crestor]SBD3ec57aa3-4399-46c9-9292-567d2a09df4f2
859421rosuvastatin calcium 40 MG Oral Tablet [Crestor]SBD3ec57aa3-4399-46c9-9292-567d2a09df4f2
859747rosuvastatin calcium 10 MG Oral TabletSCD3ec57aa3-4399-46c9-9292-567d2a09df4f2
859751rosuvastatin calcium 20 MG Oral TabletSCD3ec57aa3-4399-46c9-9292-567d2a09df4f2
859419rosuvastatin calcium 40 MG Oral TabletSCD3ec57aa3-4399-46c9-9292-567d2a09df4f2
859749Crestor 10 MG Oral TabletSY3ec57aa3-4399-46c9-9292-567d2a09df4f2
859753Crestor 20 MG Oral TabletSY3ec57aa3-4399-46c9-9292-567d2a09df4f2
859421Crestor 40 MG Oral TabletSY3ec57aa3-4399-46c9-9292-567d2a09df4f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-031-154335300311515 in 1 BOTTLE, PLASTICHistorical
43353-031-454335300314545 in 1 BOTTLE, PLASTICHistorical
43353-031-604335300316090 in 1 BOTTLE, PLASTICHistorical
43353-031-82433530031821200 in 1 BOTTLE, PLASTICHistorical
43353-031-91433530031911260 in 1 BOTTLE, PLASTICHistorical
43353-031-9943353003199600 in 1 BOTTLE, PLASTICHistorical