ROSUVASTATIN

Product NDC
49252-061
11-digit product format
492520061
Labeler code
49252
Product ID
49252-061_90429790-6bb4-40fe-bcb0-1121633523cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
rosuvastatin
Dosage form
TABLET
Route
ORAL
Labeler
Inventia Healthcare Limited
Application
ANDA207653
Marketing category
ANDA
Marketing start
2021-02-05
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49252-061-104925200611030 TABLET in 1 BOTTLE (49252-061-10) 30 tablet2021-02-050000-00-00NoNoCurrent
49252-061-124925200611290 TABLET in 1 BOTTLE (49252-061-12) 90 tablet2021-02-050000-00-00NoNoCurrent
49252-061-1749252006117500 TABLET in 1 BOTTLE (49252-061-17) 500 tablet2021-02-050000-00-00NoNoCurrent
49252-061-18492520061181000 TABLET in 1 BOTTLE (49252-061-18) 1000 tablet2021-02-050000-00-00NoNoCurrent
49252-061-574925200615710 BLISTER PACK in 1 CARTON (49252-061-57) > 10 TABLET in 1 BLISTER PACK10 blister pack2021-02-050000-00-00NoNoCurrent
49252-061-614925200616110 BLISTER PACK in 1 CARTON (49252-061-61) > 10 TABLET in 1 BLISTER PACK10 blister pack2021-02-050000-00-00NoNoCurrent