Rosuvastatin

Product NDC
71335-1446
11-digit product format
713351446
Labeler code
71335
Product ID
71335-1446_038d4ae2-9231-43ae-bc3a-c2872aa552bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207616
Marketing category
ANDA
Marketing start
2016-10-29
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1446-12024-01-30C16284748780-11030e365-1b8d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
71335-1446-22024-01-30C16284748780-11030e365-1b8d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
71335-1446-32024-01-30C16284748780-11030e365-1b8d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
71335-1446-42024-01-30C16284748780-11030e365-1b8d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
71335-1446-52024-01-30C16284748780-11030e365-1b8d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1446-17133514460130 TABLET, FILM COATED in 1 BOTTLE (71335-1446-1) 2020-01-090000-00-00NoNoCurrent
71335-1446-27133514460290 TABLET, FILM COATED in 1 BOTTLE (71335-1446-2) 2019-12-200000-00-00NoNoCurrent
71335-1446-37133514460360 TABLET, FILM COATED in 1 BOTTLE (71335-1446-3) 2021-12-280000-00-00NoNoCurrent
71335-1446-471335144604120 TABLET, FILM COATED in 1 BOTTLE (71335-1446-4) 2021-12-280000-00-00NoNoCurrent
71335-1446-571335144605180 TABLET, FILM COATED in 1 BOTTLE (71335-1446-5) 2021-12-280000-00-00NoNoCurrent