FDA.reportPublic FDA data

CRESTOR

Product NDC
50090-1097
11-digit product format
500901097
Labeler code
50090
Product ID
50090-1097_a6a453ac-b8be-471a-8ee0-7e25b9b41e83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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
2021-12-31
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
50090-1097-12023-01-30C16284748780-1f386c649-f061-0266-e053-dadaa90a7c1aThese 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
50090-1097-1CRESTOR30 in 1 BOTTLE, PLASTICTABLET, FILM COATED305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1097CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Legacy NDC, 1 package rows20200122_303f6c6c-c9ec-4a29-b2c9-2e81cc0e50f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859421CRESTOR 40 MG Oral TabletPSN303f6c6c-c9ec-4a29-b2c9-2e81cc0e50f05
859419rosuvastatin calcium 40 MG Oral TabletPSN303f6c6c-c9ec-4a29-b2c9-2e81cc0e50f05
859421rosuvastatin calcium 40 MG Oral Tablet [Crestor]SBD303f6c6c-c9ec-4a29-b2c9-2e81cc0e50f05
859419rosuvastatin calcium 40 MG Oral TabletSCD303f6c6c-c9ec-4a29-b2c9-2e81cc0e50f05
859421Crestor 40 MG Oral TabletSY303f6c6c-c9ec-4a29-b2c9-2e81cc0e50f05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1097-15009010970130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-1097-1) 2014-11-280000-00-00NoNoCurrent