Rosuvastatin Calcium

Product NDC
43547-591
11-digit product format
435470591
Labeler code
43547
Product ID
43547-591_ab55fc1d-c567-40bc-acbf-089c5a0cc091
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rosuvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Solco Healthcare LLC
Application
ANDA212059
Marketing category
ANDA
Marketing start
2021-03-10
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-591-09EA - Each43547-5912fb6e06a-e236-4519-b452-060e8aed6fec12021-04-08
43547-591-50EA - Each43547-59125b96066-2246-4d23-b052-3c40f9fdfa5612021-04-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-591-094354705910990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-591-09) 2021-03-100000-00-00NoNoCurrent
43547-591-5043547059150500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-591-50) 2021-03-100000-00-00NoNoCurrent