Crestor

Product NDC
21695-287
11-digit product format
216950287
Labeler code
21695
Product ID
21695-287_3bf80420-7482-44c0-a117-30793ba89544
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA021366
Marketing category
NDA
Marketing start
2003-11-25
Marketing end
0000-00-00
Substance
ROSUVASTATIN CALCIUM
Active strength
10 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
21695-287-102019-09-24C16284748780-1934fe258-4848-48b1-e053-8cdaa90a720a3bf80420-7482-44c0-a117-30793ba89544

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-287-10Crestor90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROSUVASTATIN CALCIUMACTIVE INGREDIENT83MVU38M7QCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ROSUVASTATIN CALCIUMACTIVE MOIETY83MVU38M7QCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TRIACETININACTIVE INGREDIENTXHX3C3X673CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-287CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110622_3bf80420-7482-44c0-a117-30793ba89544.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859749CRESTOR 10 MG Oral TabletPSN3bf80420-7482-44c0-a117-30793ba895441
859753CRESTOR 20 MG Oral TabletPSN3bf80420-7482-44c0-a117-30793ba895441
859421CRESTOR 40 MG Oral TabletPSN3bf80420-7482-44c0-a117-30793ba895441
859426CRESTOR 5 MG Oral TabletPSN3bf80420-7482-44c0-a117-30793ba895441
859747rosuvastatin calcium 10 MG Oral TabletPSN3bf80420-7482-44c0-a117-30793ba895441
859751rosuvastatin calcium 20 MG Oral TabletPSN3bf80420-7482-44c0-a117-30793ba895441
859419rosuvastatin calcium 40 MG Oral TabletPSN3bf80420-7482-44c0-a117-30793ba895441
859424rosuvastatin calcium 5 MG Oral TabletPSN3bf80420-7482-44c0-a117-30793ba895441
859749rosuvastatin calcium 10 MG Oral Tablet [Crestor]SBD3bf80420-7482-44c0-a117-30793ba895441
859753rosuvastatin calcium 20 MG Oral Tablet [Crestor]SBD3bf80420-7482-44c0-a117-30793ba895441
859421rosuvastatin calcium 40 MG Oral Tablet [Crestor]SBD3bf80420-7482-44c0-a117-30793ba895441
859426rosuvastatin calcium 5 MG Oral Tablet [Crestor]SBD3bf80420-7482-44c0-a117-30793ba895441
859747rosuvastatin calcium 10 MG Oral TabletSCD3bf80420-7482-44c0-a117-30793ba895441
859751rosuvastatin calcium 20 MG Oral TabletSCD3bf80420-7482-44c0-a117-30793ba895441
859419rosuvastatin calcium 40 MG Oral TabletSCD3bf80420-7482-44c0-a117-30793ba895441
859424rosuvastatin calcium 5 MG Oral TabletSCD3bf80420-7482-44c0-a117-30793ba895441
859749Crestor 10 MG Oral TabletSY3bf80420-7482-44c0-a117-30793ba895441
859753Crestor 20 MG Oral TabletSY3bf80420-7482-44c0-a117-30793ba895441
859421Crestor 40 MG Oral TabletSY3bf80420-7482-44c0-a117-30793ba895441
859426Crestor 5 MG Oral TabletSY3bf80420-7482-44c0-a117-30793ba895441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-287-102169502871090 in 1 BOTTLEHistorical