Rosuvastatin

Product NDC
50090-4909
11-digit product format
500904909
Labeler code
50090
Product ID
50090-4909_ce075d1d-a411-4e8e-9829-6f4bd22f881a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207616
Marketing category
ANDA
Marketing start
2016-10-29
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
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
50090-4909-0Rosuvastatin90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4909ROSUVASTATIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20210303_458ceb98-4ad2-4946-854f-3b4e53a94270.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859751rosuvastatin calcium 20 MG Oral TabletPSN458ceb98-4ad2-4946-854f-3b4e53a942701
859751rosuvastatin calcium 20 MG Oral TabletSCD458ceb98-4ad2-4946-854f-3b4e53a942701

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4909-05009049090090 TABLET, FILM COATED in 1 BOTTLE (50090-4909-0) 2020-02-180000-00-00NoNoCurrent