FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
50090-4039
11-digit product format
500904039
Labeler code
50090
Product ID
50090-4039_789adebd-5873-4fef-9173-db81569f8bd6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA201619
Marketing category
ANDA
Marketing start
2016-10-31
Marketing end
0000-00-00
Substance
ROSUVASTATIN CALCIUM
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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
50090-4039-02023-01-30C16284748780-1f386c64a-0d77-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
50090-4039-12023-01-30C16284748780-1f386c64a-0d77-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4039-0Rosuvastatin Calcium30 in 1 BOTTLETABLET, COATED304
50090-4039-1Rosuvastatin Calcium90 in 1 BOTTLE, PLASTICTABLET, COATED904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4039ROSUVASTATIN CALCIUM TABLET, COATED [A-S MEDICATION SOLUTIONS]4Legacy NDC, 2 package rows20190501_c28dd003-e432-4519-a7b2-db7c7876aa80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSNc28dd003-e432-4519-a7b2-db7c7876aa804
859747rosuvastatin calcium 10 MG Oral TabletSCDc28dd003-e432-4519-a7b2-db7c7876aa804

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4039-05009040390030 TABLET, COATED in 1 BOTTLE (50090-4039-0) 2019-01-090000-00-00NoNoCurrent
50090-4039-15009040390190 TABLET, COATED in 1 BOTTLE, PLASTIC (50090-4039-1) 2016-10-310000-00-00NoNoCurrent