FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
50090-5188
11-digit product format
500905188
Labeler code
50090
Product ID
50090-5188_b2cd4d52-3c05-4110-bbf3-28a2d7495226
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA206465
Marketing category
ANDA
Marketing start
2017-03-21
Substance
ROSUVASTATIN CALCIUM
Active strength
10 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 CALCIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
Rxcui859747

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5188-02023-02-07C16284748780-1f386c649-d692-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
50090-5188-12023-02-07C16284748780-1f386c649-d692-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
50090-5188-02023-01-30C16284748780-1f386c649-d692-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
50090-5188-12023-01-30C16284748780-1f386c649-d692-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5188-0Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED3013
50090-5188-1Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED9013
50090-5188-2Rosuvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5188-0EA - Each50090-518883ea2567-8a64-4310-b745-67e176d3e2db12023-04-07
50090-5188-1EA - Each50090-5188d8c5e5d1-ffd7-4577-a41e-f4ba78870cda12023-02-06
50090-5188-2EA - Each50090-5188ef1dbb5c-e780-441b-8458-56c9bc307aa012023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5188ROSUVASTATIN CALCIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 3 package rows20230317_ac89adcd-3226-4a66-8902-0f0a33be159a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSNac89adcd-3226-4a66-8902-0f0a33be159a13
859747rosuvastatin calcium 10 MG Oral TabletSCDac89adcd-3226-4a66-8902-0f0a33be159a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5188-05009051880030 TABLET, FILM COATED in 1 BOTTLE (50090-5188-0) 2020-09-290000-00-00NoNoCurrent
50090-5188-15009051880190 TABLET, FILM COATED in 1 BOTTLE (50090-5188-1) 2020-09-290000-00-00NoNoCurrent
50090-5188-250090518802100 TABLET, FILM COATED in 1 BOTTLE (50090-5188-2) 2023-03-13NoNoHistorical