Rosuvastatin Calcium

Product NDC
50090-7491
11-digit product format
500907491
Labeler code
50090
Product ID
50090-7491_9f790488-5053-44f7-83d5-11bb05d83e04
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
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
50090-7491-05009074910090 TABLET, FILM COATED in 1 BOTTLE (50090-7491-0) 2025-01-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rosuvastatin CalciumA-S Medication Solutions2025-01-08HUMAN PRESCRIPTION DRUG LABEL1