Rosuvastatin Calcium

Product NDC
50090-3515
11-digit product format
500903515
Labeler code
50090
Product ID
50090-3515_f1d6e4be-19b9-459b-8f79-4b4b5d9cb094
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA079172
Marketing category
ANDA
Marketing start
2016-07-19
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3515-0Rosuvastatin Calcium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED306
50090-3515-1Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3515-0EA - Each50090-3515cf16a53e-e57f-4c3c-9e44-26a6e07e419a12021-11-09
50090-3515-1EA - Each50090-351516f62d11-c7bd-4f62-a5d7-c4d3a8d4863d12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3515ROSUVASTATIN CALCIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]6Legacy NDC, 2 package rows20210417_35072655-f1f5-4b27-8c28-2b9bd89fdf9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859419rosuvastatin calcium 40 MG Oral TabletPSN35072655-f1f5-4b27-8c28-2b9bd89fdf9b6
859419rosuvastatin calcium 40 MG Oral TabletSCD35072655-f1f5-4b27-8c28-2b9bd89fdf9b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3515-05009035150030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3515-0) 2016-07-190000-00-00NoNoCurrent
50090-3515-15009035150190 TABLET, FILM COATED in 1 BOTTLE (50090-3515-1) 2018-07-260000-00-00NoNoCurrent