Rosuvastatin

Product NDC
70518-0986
11-digit product format
705180986
Labeler code
70518
Product ID
70518-0986_e2adc1e7-0903-2fb5-e053-2a95a90a7fb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207616
Marketing category
ANDA
Marketing start
2018-01-22
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0986-07051809860090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0986-0) 2018-01-220000-00-00NoNoCurrent
70518-0986-17051809860130 POUCH in 1 BOX (70518-0986-1) > 1 TABLET, FILM COATED in 1 POUCH (70518-0986-2) 30 pouch2021-02-260000-00-00NoNoCurrent