Rosuvastatin Calcium

Product NDC
71205-279
11-digit product format
712050279
Labeler code
71205
Product ID
71205-279_1b45d342-8e4c-4b95-a08f-c910ef65f335
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA079172
Marketing category
ANDA
Marketing start
2016-07-19
Substance
ROSUVASTATIN CALCIUM
Active strength
20 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
71205-279-307120502793030 TABLET, FILM COATED in 1 BOTTLE (71205-279-30) 2019-06-01NoNoHistorical
71205-279-607120502796060 TABLET, FILM COATED in 1 BOTTLE (71205-279-60) 2019-06-01NoNoHistorical
71205-279-907120502799090 TABLET, FILM COATED in 1 BOTTLE (71205-279-90) 2019-06-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rosuvastatin CalciumProficient Rx LP2022-04-01HUMAN PRESCRIPTION DRUG LABEL3