FDA.reportPublic FDA data

Crestor

Product NDC
0310-7580
11-digit product format
003107580
Labeler code
0310
Product ID
0310-7580_afc9b415-ee6f-4905-a281-13e74dcf6ce6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA021366
Marketing category
NDA
Marketing start
2022-01-24
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Crestor
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
Rxcui859419, 859421, 859424, 859426, 859747, 859749, 859751, 859753

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
0310-7580-902024-01-30C16284748780-11030e365-09ee-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CRESTOR safely and effectively. See full prescribing information for CRESTOR. CRESTOR (rosuvastatin) tablets, for oral use Initial U.S. Approval: 2003
0310-7580-902024-01-30C16284748780-11030e365-09ee-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use CRESTOR safely and effectively. See full prescribing information for CRESTOR. CRESTOR ® (rosuvastatin) tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0310-7580-90Crestor90 in 1 BOTTLETABLET, FILM COATED9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-7580-90EA - Each0310-75806120d89f-cf00-450f-9a04-40d1f3332a3212022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-7580CRESTOR (ROSUVASTATIN) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]12Current NDC, Legacy NDC, 1 package rows20240807_325a5d0e-9a72-4015-9fcd-1655fb504cee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859749CRESTOR 10 MG Oral TabletPSN325a5d0e-9a72-4015-9fcd-1655fb504cee14
859753CRESTOR 20 MG Oral TabletPSN325a5d0e-9a72-4015-9fcd-1655fb504cee14
859421CRESTOR 40 MG Oral TabletPSN325a5d0e-9a72-4015-9fcd-1655fb504cee14
859426CRESTOR 5 MG Oral TabletPSN325a5d0e-9a72-4015-9fcd-1655fb504cee14
859747rosuvastatin calcium 10 MG Oral TabletPSN325a5d0e-9a72-4015-9fcd-1655fb504cee14
859751rosuvastatin calcium 20 MG Oral TabletPSN325a5d0e-9a72-4015-9fcd-1655fb504cee14
859419rosuvastatin calcium 40 MG Oral TabletPSN325a5d0e-9a72-4015-9fcd-1655fb504cee14
859424rosuvastatin calcium 5 MG Oral TabletPSN325a5d0e-9a72-4015-9fcd-1655fb504cee14
859749rosuvastatin calcium 10 MG Oral Tablet [Crestor]SBD325a5d0e-9a72-4015-9fcd-1655fb504cee14
859753rosuvastatin calcium 20 MG Oral Tablet [Crestor]SBD325a5d0e-9a72-4015-9fcd-1655fb504cee14
859421rosuvastatin calcium 40 MG Oral Tablet [Crestor]SBD325a5d0e-9a72-4015-9fcd-1655fb504cee14
859426rosuvastatin calcium 5 MG Oral Tablet [Crestor]SBD325a5d0e-9a72-4015-9fcd-1655fb504cee14
859747rosuvastatin calcium 10 MG Oral TabletSCD325a5d0e-9a72-4015-9fcd-1655fb504cee14
859751rosuvastatin calcium 20 MG Oral TabletSCD325a5d0e-9a72-4015-9fcd-1655fb504cee14
859419rosuvastatin calcium 40 MG Oral TabletSCD325a5d0e-9a72-4015-9fcd-1655fb504cee14
859424rosuvastatin calcium 5 MG Oral TabletSCD325a5d0e-9a72-4015-9fcd-1655fb504cee14
859749Crestor 10 MG Oral TabletSY325a5d0e-9a72-4015-9fcd-1655fb504cee14
859753Crestor 20 MG Oral TabletSY325a5d0e-9a72-4015-9fcd-1655fb504cee14
859421Crestor 40 MG Oral TabletSY325a5d0e-9a72-4015-9fcd-1655fb504cee14
859426Crestor 5 MG Oral TabletSY325a5d0e-9a72-4015-9fcd-1655fb504cee14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0310-7580-900031075809090 TABLET, FILM COATED in 1 BOTTLE (0310-7580-90) 2022-01-240000-00-00NoNoCurrent