ROSUVASTATIN CALCIUM

Product NDC
43353-332
11-digit product format
433530332
Labeler code
43353
Product ID
43353-332_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
20 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
43353-332-15EA - Each43353-332f01a5dc8-982a-4868-9fcb-64eb113e0f3012018-01-12
43353-332-17EA - Each43353-332e1460d61-53a9-4319-aabc-efecf2e114df12018-01-12
43353-332-45EA - Each43353-3323c8842d5-4ffb-40a8-bc42-06afc076fcb412018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-332ROSUVASTATIN 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
43353-332-154335303321515 TABLET in 1 BOTTLE (43353-332-15) 15 tablet2017-07-050000-00-00NoNoCurrent
43353-332-17433530332176030 TABLET in 1 BOTTLE (43353-332-17) 6030 tablet2017-05-250000-00-00NoNoCurrent
43353-332-454335303324545 TABLET in 1 BOTTLE (43353-332-45) 45 tablet2017-07-050000-00-00NoNoCurrent