ROSZET

These highlights do not include all the information needed to use ROSZET safely and effectively. See full prescribing information for ROSZET. ROSZET (rosuvastatin and ezetimibe) tablets, for oral useInitial U.S. Approval: 2021

Approved

Approval ID

1653b3c4-2b2a-408b-918a-c687918c6265

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 15, 2021

Manufacturers

FDA

Althera Pharmaceuticals LLC

DUNS: 116817996

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

(rosuvastatin and ezetimibe)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code70661-003

Application NumberNDA213072

Product Classification

Marketing Category

C73594

Generic Name

(rosuvastatin and ezetimibe)

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 15, 2021

FDA Product Classification

INGREDIENTS (18)

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

ROSUVASTATIN CALCIUMActive

Quantity: 20.8 mg in 1 1

Code: 83MVU38M7Q

Classification: ACTIM

EZETIMIBEActive

Quantity: 10 mg in 1 1

Code: EOR26LQQ24

Classification: ACTIB

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive

Code: O7TSZ97GEP

Classification: IACT

MEGLUMINEInactive

Code: 6HG8UB2MUY

Classification: IACT

CROSPOVIDONEInactive

Code: 2S7830E561

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UI

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

rosuvastatin and ezetimibe

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code70661-001

Application NumberNDA213072

Product Classification

Marketing Category

C73594

Generic Name

rosuvastatin and ezetimibe

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 15, 2021

FDA Product Classification

INGREDIENTS (18)

EZETIMIBEActive

Quantity: 10 mg in 1 1

Code: EOR26LQQ24

Classification: ACTIB

ROSUVASTATIN CALCIUMActive

Quantity: 5.2 mg in 1 1

Code: 83MVU38M7Q

Classification: ACTIM

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive

Code: O7TSZ97GEP

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MEGLUMINEInactive

Code: 6HG8UB2MUY

Classification: IACT

CROSPOVIDONEInactive

Code: 2S7830E561

Classification: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UI

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

(rosuvastatin and ezetimibe)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code70661-002

Application NumberNDA213072

Product Classification

Marketing Category

C73594

Generic Name

(rosuvastatin and ezetimibe)

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 15, 2021

FDA Product Classification

INGREDIENTS (18)

ROSUVASTATIN CALCIUMActive

Quantity: 10.4 mg in 1 1

Code: 83MVU38M7Q

Classification: ACTIM

EZETIMIBEActive

Quantity: 10 mg in 1 1

Code: EOR26LQQ24

Classification: ACTIB

MEGLUMINEInactive

Code: 6HG8UB2MUY

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

CROSPOVIDONEInactive

Code: 2S7830E561

Classification: IACT

DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive

Code: O7TSZ97GEP

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UI

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

(rosuvastatin and ezetimibe)

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code70661-004

Application NumberNDA213072

Product Classification

Marketing Category

C73594

Generic Name

(rosuvastatin and ezetimibe)

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 15, 2021

FDA Product Classification

INGREDIENTS (18)

EZETIMIBEActive

Quantity: 10 mg in 1 1

Code: EOR26LQQ24

Classification: ACTIB

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

MEGLUMINEInactive

Code: 6HG8UB2MUY

Classification: IACT

CROSPOVIDONEInactive

Code: 2S7830E561

Classification: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48

Classification: IACT

SODIUM STEARYL FUMARATEInactive

Code: 7CV7WJK4UI

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

ROSUVASTATIN CALCIUMActive

Quantity: 41.7 mg in 1 1

Code: 83MVU38M7Q

Classification: ACTIM

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive

Code: O7TSZ97GEP

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

POVIDONEInactive

Code: FZ989GH94E

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

HYPROMELLOSE, UNSPECIFIEDInactive

Code: 3NXW29V3WO

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1A

Classification: IACT

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ROSZET

Products 4

(rosuvastatin and ezetimibe)

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

rosuvastatin and ezetimibe

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

(rosuvastatin and ezetimibe)

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

(rosuvastatin and ezetimibe)

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (18)

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