Rosuvastatin calcium

Product NDC
0781-5401
11-digit product format
007815401
Labeler code
0781
Product ID
0781-5401_04d6d11e-f5fa-4dc8-8af7-a4983ddcb8de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA079171
Marketing category
ANDA
Marketing start
2016-07-19
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-5401-920078154019290 TABLET, FILM COATED in 1 BOTTLE (0781-5401-92) 2016-07-190000-00-00NoNoCurrent