FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
50090-2805
11-digit product format
500902805
Labeler code
50090
Product ID
50090-2805_55a5ddb7-f870-4167-930a-ceaeffcf1eb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin calcium
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA079167
Marketing category
ANDA
Marketing start
2016-05-02
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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
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
50090-2805-02020-01-31C16284748780-19d75b9d0-0c37-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ROSUVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN CALCIUM TABLETS . ROSUVASTATIN CALCIUM tablets , for oral use Initial U.S. Approval: 2003
50090-2805-12020-01-31C16284748780-19d75b9d0-0c37-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ROSUVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN CALCIUM TABLETS . ROSUVASTATIN CALCIUM tablets , for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2805-0Rosuvastatin Calcium30 in 1 BOTTLETABLET306
50090-2805-1Rosuvastatin Calcium90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2805ROSUVASTATIN CALCIUM TABLET [A-S MEDICATION SOLUTIONS]6Legacy NDC, 2 package rows20190225_965f8208-1bd7-4194-957a-749aecf0a89e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859419rosuvastatin calcium 40 MG Oral TabletPSN965f8208-1bd7-4194-957a-749aecf0a89e6
859419rosuvastatin calcium 40 MG Oral TabletSCD965f8208-1bd7-4194-957a-749aecf0a89e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-2805-05009028050030 in 1 BOTTLEHistorical
50090-2805-15009028050190 in 1 BOTTLEHistorical