Rosuvastatin calcium

Product NDC
50090-5970
11-digit product format
500905970
Labeler code
50090
Product ID
50090-5970_252921c9-9d25-414b-9dc9-40585f49ba83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207752
Marketing category
ANDA
Marketing start
2016-10-31
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
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
50090-5970-05009059700030 TABLET, FILM COATED in 1 BOTTLE (50090-5970-0) 2022-04-28NoNoHistorical
50090-5970-15009059700190 TABLET, FILM COATED in 1 BOTTLE (50090-5970-1) 2022-05-04NoNoHistorical
50090-5970-250090597002100 TABLET, FILM COATED in 1 BOTTLE (50090-5970-2) 2023-04-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rosuvastatin calciumA-S Medication Solutions2023-09-14HUMAN PRESCRIPTION DRUG LABEL3