Rosuvastatin

Product NDC
50090-7483
11-digit product format
500907483
Labeler code
50090
Product ID
50090-7483_c8420ae8-aa88-4016-a3a8-2f1d87908f8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206381
Marketing category
ANDA
Marketing start
2019-04-24
Substance
ROSUVASTATIN
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
413KH5ZJ73ROSUVASTATIN287714-41-4ROSUVASTATIN

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7483-05009074830090 TABLET, FILM COATED in 1 BOTTLE (50090-7483-0) 2024-12-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
RosuvastatinA-S Medication Solutions2025-10-10HUMAN PRESCRIPTION DRUG LABEL3
RosuvastatinA-S Medication Solutions2024-12-30HUMAN PRESCRIPTION DRUG LABEL1