Rosuvastatin calcium

Product NDC
59746-431
11-digit product format
597460431
Labeler code
59746
Product ID
59746-431_f7e4af28-33ff-42d7-bfe9-35ddce10b977
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Jubilant Cadista Pharmaceuticals Inc.
Application
ANDA207062
Marketing category
ANDA
Marketing start
2016-10-31
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
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59746-431ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.]4Legacy NDC20191202_ef882889-ce8e-0992-c2dc-d00477e411f4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59746-431-0159746043101100 TABLET, FILM COATED in 1 BOTTLE (59746-431-01) 2016-10-310000-00-00NoNoCurrent
59746-431-10597460431101000 TABLET, FILM COATED in 1 BOTTLE (59746-431-10) 2016-10-310000-00-00NoNoCurrent
59746-431-305974604313030 TABLET, FILM COATED in 1 BOTTLE (59746-431-30) 2016-10-310000-00-00NoNoCurrent
59746-431-905974604319090 TABLET, FILM COATED in 1 BOTTLE (59746-431-90) 2016-10-310000-00-00NoNoCurrent