FDA.reportPublic FDA data

CRESTOR

Product NDC
68151-4634
11-digit product format
681514634
Labeler code
68151
Product ID
68151-4634_0b414272-4c09-49a0-af47-bf61498e294c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA021366
Marketing category
NDA
Marketing start
2003-08-18
Marketing end
0000-00-00
Substance
ROSUVASTATIN CALCIUM
Active strength
5 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
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
68151-4634-92020-01-31C16284748780-19d75b9d0-4c42-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
68151-4634-9CRESTOR1 in 1 PACKAGETABLET, FILM COATED13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROSUVASTATIN CALCIUMACTIVE INGREDIENT83MVU38M7QCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
ROSUVASTATINACTIVE MOIETY413KH5ZJ73CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
TRIACETININACTIVE INGREDIENTXHX3C3X673CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4634CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20160806_c5b121bc-cb72-4411-856d-aa71b40bb660.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859426CRESTOR 5 MG Oral TabletPSNc5b121bc-cb72-4411-856d-aa71b40bb6603
859424rosuvastatin calcium 5 MG Oral TabletPSNc5b121bc-cb72-4411-856d-aa71b40bb6603
859426rosuvastatin calcium 5 MG Oral Tablet [Crestor]SBDc5b121bc-cb72-4411-856d-aa71b40bb6603
859424rosuvastatin calcium 5 MG Oral TabletSCDc5b121bc-cb72-4411-856d-aa71b40bb6603
859426Crestor 5 MG Oral TabletSYc5b121bc-cb72-4411-856d-aa71b40bb6603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4634-9681514634091 in 1 PACKAGEHistorical