FDA.reportPublic FDA data

Rosuvastatin

Product NDC
68071-2816
11-digit product format
680712816
Labeler code
68071
Product ID
68071-2816_e673e040-593f-f9dd-e053-2995a90a0917
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA206434
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2816-22025-01-30C16284748780-12cef2736-8dbd-d83d-e063-dadaa90ab31fThese 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
68071-2816-2Rosuvastatin120 in 1 BOTTLETABLET, FILM COATED1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2816ROSUVASTATIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20220819_e673ddcb-884b-e62d-e053-2995a90acc44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSNe673ddcb-884b-e62d-e053-2995a90acc441
859747rosuvastatin calcium 10 MG Oral TabletSCDe673ddcb-884b-e62d-e053-2995a90acc441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2816-268071281602120 TABLET, FILM COATED in 1 BOTTLE (68071-2816-2) 2022-08-170000-00-00NoNoCurrent