FDA.reportPublic FDA data

Rosuvastatin calcium

Product NDC
50090-6302
11-digit product format
500906302
Labeler code
50090
Product ID
50090-6302_490ce2bb-b8b1-4748-9515-97834eeed97f
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
Substance
ROSUVASTATIN CALCIUM
Active strength
5 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rosuvastatin calcium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
Rxcui859424

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6302-0Rosuvastatin calcium30 in 1 BOTTLETABLET, FILM COATED308
50090-6302-1Rosuvastatin calcium90 in 1 BOTTLETABLET, FILM COATED908
50090-6302-2Rosuvastatin calcium100 in 1 BOTTLETABLET, FILM COATED1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6302-0EA - Each50090-6302c551ab03-2112-4588-ace3-b061170fff0212023-02-06
50090-6302-1EA - Each50090-6302bff27f7e-afea-4629-b730-1e7ad7c9782b12023-02-06
50090-6302-2EA - Each50090-630291467625-6f12-4b4b-bb5c-3463979fc94312023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6302ROSUVASTATIN CALCIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 3 package rows20240612_f07922e5-a963-4ecf-86db-c1ae12f85224.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859424rosuvastatin calcium 5 MG Oral TabletPSNf07922e5-a963-4ecf-86db-c1ae12f852248
859424rosuvastatin calcium 5 MG Oral TabletSCDf07922e5-a963-4ecf-86db-c1ae12f852248

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-6302-05009063020030 TABLET, FILM COATED in 1 BOTTLE (50090-6302-0) 2022-12-290000-00-00NoNoCurrent
50090-6302-15009063020190 TABLET, FILM COATED in 1 BOTTLE (50090-6302-1) 2022-12-290000-00-00NoNoCurrent
50090-6302-250090630202100 TABLET, FILM COATED in 1 BOTTLE (50090-6302-2) 2023-03-13NoNoHistorical