Rosuvastatin calcium

Product NDC
50090-3437
11-digit product format
500903437
Labeler code
50090
Product ID
50090-3437_19da328b-50eb-4c92-8778-7b3fe1a0ddee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROSUVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206434
Marketing category
ANDA
Marketing start
2016-10-31
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3437-0Rosuvastatin calcium30 in 1 BOTTLETABLET, FILM COATED303
50090-3437-1Rosuvastatin calcium90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3437-0EA - Each50090-3437defc94ee-572f-4ae5-9626-a0ea01e22efc12019-05-02
50090-3437-1EA - Each50090-3437c93bea7b-8d9b-46fa-adea-4397086aee2f12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3437ROSUVASTATIN CALCIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 2 package rows20200121_73bcb15c-5529-4589-b242-ed23e1e0f08b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859419rosuvastatin calcium 40 MG Oral TabletPSN73bcb15c-5529-4589-b242-ed23e1e0f08b3
859419rosuvastatin calcium 40 MG Oral TabletSCD73bcb15c-5529-4589-b242-ed23e1e0f08b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3437-05009034370030 TABLET, FILM COATED in 1 BOTTLE (50090-3437-0) 2018-04-170000-00-00NoNoCurrent
50090-3437-15009034370190 TABLET, FILM COATED in 1 BOTTLE (50090-3437-1) 2018-04-160000-00-00NoNoCurrent