FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
71335-0905
11-digit product format
713350905
Labeler code
71335
Product ID
71335-0905_33dc6bb6-6f8a-1975-e063-6294a90af45e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207408
Marketing category
ANDA
Marketing start
2018-01-08
Substance
ROSUVASTATIN CALCIUM
Active strength
20 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 CALCIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
Rxcui859751

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
71335-0905-12024-05-16C16284748780-11030e365-1e4d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ROSUVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN CALCIUM TABLETS. ROSUVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 2003
71335-0905-22024-05-16C16284748780-11030e365-1e4d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ROSUVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN CALCIUM TABLETS. ROSUVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 2003
71335-0905-32024-05-16C16284748780-11030e365-1e4d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ROSUVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN CALCIUM TABLETS. ROSUVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 2003
71335-0905-42024-05-16C16284748780-11030e365-1e4d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ROSUVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN CALCIUM TABLETS. ROSUVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 2003
71335-0905-52024-05-16C16284748780-11030e365-1e4d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ROSUVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN CALCIUM TABLETS. ROSUVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 2003
71335-0905-62024-05-16C16284748780-11030e365-1e4d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ROSUVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN CALCIUM TABLETS. ROSUVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 2003
71335-0905-12024-01-30C16284748780-11030e365-1e4d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ROSUVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN CALCIUM TABLETS. ROSUVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 2003
71335-0905-22024-01-30C16284748780-11030e365-1e4d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ROSUVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN CALCIUM TABLETS. ROSUVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 2003
71335-0905-32024-01-30C16284748780-11030e365-1e4d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ROSUVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN CALCIUM TABLETS. ROSUVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 2003
71335-0905-42024-01-30C16284748780-11030e365-1e4d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ROSUVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN CALCIUM TABLETS. ROSUVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 2003
71335-0905-52024-01-30C16284748780-11030e365-1e4d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ROSUVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN CALCIUM TABLETS. ROSUVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 2003
71335-0905-62024-01-30C16284748780-11030e365-1e4d-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use ROSUVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN CALCIUM TABLETS. ROSUVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0905-1Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED307
71335-0905-2Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED907
71335-0905-3Rosuvastatin Calcium28 in 1 BOTTLETABLET, FILM COATED287
71335-0905-4Rosuvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED607
71335-0905-5Rosuvastatin Calcium180 in 1 BOTTLETABLET, FILM COATED1807
71335-0905-6Rosuvastatin Calcium120 in 1 BOTTLETABLET, FILM COATED1207

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0905ROSUVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 6 package rows20250429_ebb0c5d6-d816-44fa-8422-82aa63076d55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859751rosuvastatin calcium 20 MG Oral TabletPSNebb0c5d6-d816-44fa-8422-82aa63076d557
859751rosuvastatin calcium 20 MG Oral TabletSCDebb0c5d6-d816-44fa-8422-82aa63076d557

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0905-17133509050130 TABLET, FILM COATED in 1 BOTTLE (71335-0905-1) 2018-08-230000-00-00NoNoCurrent
71335-0905-27133509050290 TABLET, FILM COATED in 1 BOTTLE (71335-0905-2) 2018-07-110000-00-00NoNoCurrent
71335-0905-37133509050328 TABLET, FILM COATED in 1 BOTTLE (71335-0905-3) 2021-12-270000-00-00NoNoCurrent
71335-0905-47133509050460 TABLET, FILM COATED in 1 BOTTLE (71335-0905-4) 2021-12-270000-00-00NoNoCurrent
71335-0905-571335090505180 TABLET, FILM COATED in 1 BOTTLE (71335-0905-5) 2021-12-270000-00-00NoNoCurrent
71335-0905-671335090506120 TABLET, FILM COATED in 1 BOTTLE (71335-0905-6) 2021-12-270000-00-00NoNoCurrent