ROSUVASTATIN CALCIUM

Product NDC
43353-352
11-digit product format
433530352
Labeler code
43353
Product ID
43353-352_6398df0f-8c43-4428-b882-3f5efb53ae00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROSUVASTATIN CALCIUM
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA079170
Marketing category
ANDA
Marketing start
2017-02-02
Marketing end
0000-00-00
Substance
ROSUVASTATIN CALCIUM
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-352-15EA - Each43353-35234315606-3e41-4d0f-bec7-5b06b6d068e212017-12-14
43353-352-18EA - Each43353-352a372fff4-9333-4719-9497-d4d645b1be5012017-12-14
43353-352-19EA - Each43353-35290a21d09-2b3c-4823-b15d-7d312ace6b6212017-12-14
43353-352-45EA - Each43353-352df0cace8-1c94-422e-907e-460dc942319712017-12-14
43353-352-60EA - Each43353-352c7d8ce9c-f1f9-45f9-951a-8c2e719b6d2d12017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-352ROSUVASTATIN CALCIUM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20170714_15e4e32c-e9d4-4bff-9529-448a4f066fd1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-352-154335303521515 TABLET in 1 BOTTLE (43353-352-15) 15 tablet2017-06-010000-00-00NoNoCurrent
43353-352-18433530352183000 TABLET in 1 BOTTLE (43353-352-18) 3000 tablet2017-05-040000-00-00NoNoCurrent
43353-352-19433530352193060 TABLET in 1 BOTTLE (43353-352-19) 3060 tablet2017-05-260000-00-00NoNoCurrent
43353-352-454335303524545 TABLET in 1 BOTTLE (43353-352-45) 45 tablet2017-05-120000-00-00NoNoCurrent
43353-352-604335303526090 TABLET in 1 BOTTLE (43353-352-60) 90 tablet2017-05-110000-00-00NoNoCurrent