FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
50090-5116
11-digit product format
500905116
Labeler code
50090
Product ID
50090-5116_e3720c31-7881-43ee-9564-c06b2777481e
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
5 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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
50090-5116-02023-01-30C16284748780-1f386c649-e901-0266-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
50090-5116-12023-01-30C16284748780-1f386c649-e901-0266-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
50090-5116-0Rosuvastatin Calcium30 in 1 BOTTLETABLET, COATED303
50090-5116-1Rosuvastatin Calcium90 in 1 BOTTLETABLET, COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5116ROSUVASTATIN CALCIUM TABLET, COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20210303_8a300870-2012-42de-8e4c-74f5b70d31b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859424rosuvastatin calcium 5 MG Oral TabletPSN8a300870-2012-42de-8e4c-74f5b70d31b43
859424rosuvastatin calcium 5 MG Oral TabletSCD8a300870-2012-42de-8e4c-74f5b70d31b43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5116-05009051160030 TABLET, COATED in 1 BOTTLE (50090-5116-0) 2020-07-310000-00-00NoNoCurrent
50090-5116-15009051160190 TABLET, COATED in 1 BOTTLE (50090-5116-1) 2020-07-310000-00-00NoNoCurrent