Rosuvastatin Calcium

Product NDC
50090-5771
11-digit product format
500905771
Labeler code
50090
Product ID
50090-5771_75f25202-82d2-4f63-a2d2-4dc6d703db79
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
10 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
50090-5771-05009057710090 TABLET, FILM COATED in 1 BOTTLE (50090-5771-0) 2021-10-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rosuvastatin CalciumA-S Medication Solutions2023-09-06Human Prescription Drug Label5