ROSUVASTATIN CALCIUM

Product NDC
43353-332
11-digit product format
433530332
Labeler code
43353
Product ID
43353-332_6398df0f-8c43-4428-b882-3f5efb53ae00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROSUVASTATIN CALCIUM
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA079170
Marketing category
ANDA
Marketing start
2017-02-02
Marketing end
0000-00-00
Substance
ROSUVASTATIN CALCIUM
Active strength
20 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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
83MVU38M7QROSUVASTATIN CALCIUM147098-20-2ROSUVASTATIN CALCIUM

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-332-154335303321515 TABLET in 1 BOTTLE (43353-332-15) 15 tablet2017-07-050000-00-00NoNoCurrent
43353-332-17433530332176030 TABLET in 1 BOTTLE (43353-332-17) 6030 tablet2017-05-250000-00-00NoNoCurrent
43353-332-454335303324545 TABLET in 1 BOTTLE (43353-332-45) 45 tablet2017-07-050000-00-00NoNoCurrent