Rosuvastatin Calcium

Product NDC
71205-820
11-digit product format
712050820
Labeler code
71205
Product ID
71205-820_76bbea68-52d8-4ba9-a772-0ba75a38f2eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA206465
Marketing category
ANDA
Marketing start
2017-03-21
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
71205-820-307120508203030 TABLET, FILM COATED in 1 BOTTLE (71205-820-30) 2023-07-06NoNoHistorical
71205-820-607120508206060 TABLET, FILM COATED in 1 BOTTLE (71205-820-60) 2023-07-06NoNoHistorical
71205-820-907120508209090 TABLET, FILM COATED in 1 BOTTLE (71205-820-90) 2023-07-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rosuvastatin CalciumProficient Rx LP2023-07-01HUMAN PRESCRIPTION DRUG LABEL1