Rosuvastatin Calcium

Product NDC
50090-7492
11-digit product format
500907492
Labeler code
50090
Product ID
50090-7492_650a42f2-ca25-4cb0-95ef-3c55383fa4d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207062
Marketing category
ANDA
Marketing start
2024-12-01
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
50090-7492-05009074920030 TABLET, FILM COATED in 1 BOTTLE (50090-7492-0) 2025-01-07NoNoHistorical
50090-7492-15009074920190 TABLET, FILM COATED in 1 BOTTLE (50090-7492-1) 2025-01-07NoNoHistorical
50090-7492-250090749202100 TABLET, FILM COATED in 1 BOTTLE (50090-7492-2) 2025-01-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rosuvastatin CalciumA-S Medication Solutions2025-01-14HUMAN PRESCRIPTION DRUG LABEL1