FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
50090-5110
11-digit product format
500905110
Labeler code
50090
Product ID
50090-5110_9a8c55a7-53b4-4b5c-b478-cdbb2d86fcaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208898
Marketing category
ANDA
Marketing start
2017-11-22
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5110-02023-02-07C16284748780-1f386c649-c398-0266-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
50090-5110-12023-02-07C16284748780-1f386c649-c398-0266-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
50090-5110-02023-01-30C16284748780-1f386c649-c398-0266-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
50090-5110-12023-01-30C16284748780-1f386c649-c398-0266-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
50090-5110-0Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED309
50090-5110-1Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED909
50090-5110-2Rosuvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5110-0EA - Each50090-511094f0673b-d915-44ff-a234-a0b7d7f4cbdb12024-09-09
50090-5110-1EA - Each50090-51108b36f455-ca0e-40d0-bd2e-846d91a8c05e12024-09-09
50090-5110-2EA - Each50090-51101ac1c53c-3237-41df-85f0-73982499b45e12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5110ROSUVASTATIN CALCIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 3 package rows20240821_aaadbf01-9cf4-4898-9a96-f0a20d55702b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859424rosuvastatin calcium 5 MG Oral TabletPSNaaadbf01-9cf4-4898-9a96-f0a20d55702b9
859424rosuvastatin calcium 5 MG Oral TabletSCDaaadbf01-9cf4-4898-9a96-f0a20d55702b9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5110-05009051100030 TABLET, FILM COATED in 1 BOTTLE (50090-5110-0) 2020-07-230000-00-00NoNoCurrent
50090-5110-15009051100190 TABLET, FILM COATED in 1 BOTTLE (50090-5110-1) 2020-07-230000-00-00NoNoCurrent
50090-5110-250090511002100 TABLET, FILM COATED in 1 BOTTLE (50090-5110-2) 2024-08-14NoNoCurrent