FDA.reportPublic FDA data

CRESTOR

Product NDC
0310-0751
11-digit product format
003100751
Labeler code
0310
Product ID
0310-0751_d9298e4d-e35f-4ba4-9fdf-1a8d0358707f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AstraZeneca Pharmaceuticals LP
Application
NDA021366
Marketing category
NDA
Marketing start
2003-08-18
Marketing end
2024-04-30
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
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-0751-39EA - Each0310-07512ee76cc4-7154-42b7-800f-6c9ab32da94312012-07-24
0310-0751-90EA - Each0310-07515ab97476-4910-4723-b448-31291a2b1ff912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ROSUVASTATIN CALCIUMACTIVE INGREDIENT83MVU38M7QCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
ROSUVASTATINACTIVE MOIETY413KH5ZJ73CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TRIACETININACTIVE INGREDIENTXHX3C3X673CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]3
ROSUVASTATIN CALCIUMACTIVE INGREDIENT83MVU38M7QCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
ROSUVASTATINACTIVE MOIETY413KH5ZJ73CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TRIACETININACTIVE INGREDIENTXHX3C3X673CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TRIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENT91D9GV0Z28CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859749CRESTOR 10 MG Oral TabletPSNab9f816e-df48-4d90-b8ca-98477659531a3
859753CRESTOR 20 MG Oral TabletPSNab9f816e-df48-4d90-b8ca-98477659531a3
859421CRESTOR 40 MG Oral TabletPSNab9f816e-df48-4d90-b8ca-98477659531a3
859426CRESTOR 5 MG Oral TabletPSNab9f816e-df48-4d90-b8ca-98477659531a3
859747rosuvastatin calcium 10 MG Oral TabletPSNab9f816e-df48-4d90-b8ca-98477659531a3
859751rosuvastatin calcium 20 MG Oral TabletPSNab9f816e-df48-4d90-b8ca-98477659531a3
859419rosuvastatin calcium 40 MG Oral TabletPSNab9f816e-df48-4d90-b8ca-98477659531a3
859424rosuvastatin calcium 5 MG Oral TabletPSNab9f816e-df48-4d90-b8ca-98477659531a3
859749rosuvastatin calcium 10 MG Oral Tablet [Crestor]SBDab9f816e-df48-4d90-b8ca-98477659531a3
859753rosuvastatin calcium 20 MG Oral Tablet [Crestor]SBDab9f816e-df48-4d90-b8ca-98477659531a3
859421rosuvastatin calcium 40 MG Oral Tablet [Crestor]SBDab9f816e-df48-4d90-b8ca-98477659531a3
859426rosuvastatin calcium 5 MG Oral Tablet [Crestor]SBDab9f816e-df48-4d90-b8ca-98477659531a3
859747rosuvastatin calcium 10 MG Oral TabletSCDab9f816e-df48-4d90-b8ca-98477659531a3
859751rosuvastatin calcium 20 MG Oral TabletSCDab9f816e-df48-4d90-b8ca-98477659531a3
859419rosuvastatin calcium 40 MG Oral TabletSCDab9f816e-df48-4d90-b8ca-98477659531a3
859424rosuvastatin calcium 5 MG Oral TabletSCDab9f816e-df48-4d90-b8ca-98477659531a3
859749Crestor 10 MG Oral TabletSYab9f816e-df48-4d90-b8ca-98477659531a3
859753Crestor 20 MG Oral TabletSYab9f816e-df48-4d90-b8ca-98477659531a3
859421Crestor 40 MG Oral TabletSYab9f816e-df48-4d90-b8ca-98477659531a3
859426Crestor 5 MG Oral TabletSYab9f816e-df48-4d90-b8ca-98477659531a3
859749CRESTOR 10 MG Oral TabletPSN3ec57aa3-4399-46c9-9292-567d2a09df4f2
859753CRESTOR 20 MG Oral TabletPSN3ec57aa3-4399-46c9-9292-567d2a09df4f2
859421CRESTOR 40 MG Oral TabletPSN3ec57aa3-4399-46c9-9292-567d2a09df4f2
859747rosuvastatin calcium 10 MG Oral TabletPSN3ec57aa3-4399-46c9-9292-567d2a09df4f2
859751rosuvastatin calcium 20 MG Oral TabletPSN3ec57aa3-4399-46c9-9292-567d2a09df4f2
859419rosuvastatin calcium 40 MG Oral TabletPSN3ec57aa3-4399-46c9-9292-567d2a09df4f2
859749rosuvastatin calcium 10 MG Oral Tablet [Crestor]SBD3ec57aa3-4399-46c9-9292-567d2a09df4f2
859753rosuvastatin calcium 20 MG Oral Tablet [Crestor]SBD3ec57aa3-4399-46c9-9292-567d2a09df4f2
859421rosuvastatin calcium 40 MG Oral Tablet [Crestor]SBD3ec57aa3-4399-46c9-9292-567d2a09df4f2
859747rosuvastatin calcium 10 MG Oral TabletSCD3ec57aa3-4399-46c9-9292-567d2a09df4f2
859751rosuvastatin calcium 20 MG Oral TabletSCD3ec57aa3-4399-46c9-9292-567d2a09df4f2
859419rosuvastatin calcium 40 MG Oral TabletSCD3ec57aa3-4399-46c9-9292-567d2a09df4f2
859749Crestor 10 MG Oral TabletSY3ec57aa3-4399-46c9-9292-567d2a09df4f2
859753Crestor 20 MG Oral TabletSY3ec57aa3-4399-46c9-9292-567d2a09df4f2
859421Crestor 40 MG Oral TabletSY3ec57aa3-4399-46c9-9292-567d2a09df4f2
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0310-0751-900031007519090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-0751-90) 2003-08-180000-00-00NoNoCurrent