Rosuvastatin Calcium

Product NDC
55154-8099
11-digit product format
551548099
Labeler code
55154
Product ID
55154-8099_325aec56-170f-475e-9d6b-721b9d5d5ea9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-8099ROSUVASTATIN CALCIUM TABLET, COATED [CARDINAL HEALTH 107, LLC]9Legacy NDC20241122_a75fad8e-a72e-49be-bd5c-8203a74267a6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-8099-05515480990010 BLISTER PACK in 1 BAG (55154-8099-0) > 1 TABLET, COATED in 1 BLISTER PACK10 blister pack2016-10-310000-00-00NoNoCurrent