FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
50090-5770
11-digit product format
500905770
Labeler code
50090
Product ID
50090-5770_b234305b-f0b3-4140-a717-60e24f2f0699
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
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
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5770-02023-02-06C16284748780-1f386c64a-2eb8-0266-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
50090-5770-12023-02-06C16284748780-1f386c64a-2eb8-0266-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
50090-5770-02023-01-30C16284748780-1f386c64a-2eb8-0266-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
50090-5770-12023-01-30C16284748780-1f386c64a-2eb8-0266-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
50090-5770-0Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED305
50090-5770-1Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED905
50090-5770-2Rosuvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5770-0EA - Each50090-5770e58a70e5-e66a-47c1-a105-7083b26da2af12023-10-16
50090-5770-1EA - Each50090-57702e3e6ca8-87f4-4db3-83fe-6ec6b5dcacbb12023-10-16
50090-5770-2EA - Each50090-57704373c44f-0aec-460e-b69e-d5991bd4ea2812023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5770ROSUVASTATIN CALCIUM TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 3 package rows20230907_3a138e43-f123-47d1-b241-d3bcc7584e51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN3a138e43-f123-47d1-b241-d3bcc7584e515
859747rosuvastatin calcium 10 MG Oral TabletSCD3a138e43-f123-47d1-b241-d3bcc7584e515

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5770-05009057700030 TABLET, FILM COATED in 1 BOTTLE (50090-5770-0) 2021-10-050000-00-00NoNoCurrent
50090-5770-15009057700190 TABLET, FILM COATED in 1 BOTTLE (50090-5770-1) 2021-10-050000-00-00NoNoCurrent
50090-5770-250090577002100 TABLET, FILM COATED in 1 BOTTLE (50090-5770-2) 2023-09-01NoNoHistorical