Rosuvastatin Calcium

Product NDC
50090-5110
11-digit product format
500905110
Labeler code
50090
Product ID
50090-5110_9a8c55a7-53b4-4b5c-b478-cdbb2d86fcaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208898
Marketing category
ANDA
Marketing start
2017-11-22
Substance
ROSUVASTATIN CALCIUM
Active strength
5 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

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

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-5110-05009051100030 TABLET, FILM COATED in 1 BOTTLE (50090-5110-0) 2020-07-23NoNoHistorical
50090-5110-15009051100190 TABLET, FILM COATED in 1 BOTTLE (50090-5110-1) 2020-07-23NoNoHistorical
50090-5110-250090511002100 TABLET, FILM COATED in 1 BOTTLE (50090-5110-2) 2024-08-14NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rosuvastatin CalciumA-S Medication Solutions2024-08-20Human Prescription Drug Label9