ROSUVASTATIN

Product NDC
49252-062
11-digit product format
492520062
Labeler code
49252
Product ID
49252-062_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
10 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
49252-062-104925200621030 TABLET in 1 BOTTLE (49252-062-10) 30 tablet2021-02-050000-00-00NoNoCurrent
49252-062-124925200621290 TABLET in 1 BOTTLE (49252-062-12) 90 tablet2021-02-050000-00-00NoNoCurrent
49252-062-1749252006217500 TABLET in 1 BOTTLE (49252-062-17) 500 tablet2021-02-050000-00-00NoNoCurrent
49252-062-18492520062181000 TABLET in 1 BOTTLE (49252-062-18) 1000 tablet2021-02-050000-00-00NoNoCurrent
49252-062-574925200625710 BLISTER PACK in 1 CARTON (49252-062-57) > 10 TABLET in 1 BLISTER PACK10 blister pack2021-02-050000-00-00NoNoCurrent
49252-062-614925200626110 BLISTER PACK in 1 CARTON (49252-062-61) > 10 TABLET in 1 BLISTER PACK10 blister pack2021-02-050000-00-00NoNoCurrent