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Rosuvastatin Calcium

These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral useInitial U.S. Approval: 2003

Approved
Approval ID

40c2900e-4659-49ce-ba4b-5df529b3c53b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 11, 2020

Manufacturers
FDA

Zhejiang Yongtai Pharmaceutical Co., Ltd.

DUNS: 544302778

Products 4

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

rosuvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69434-008
Application NumberANDA212059
Product Classification
M
Marketing Category
C73584
G
Generic Name
rosuvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 11, 2020
FDA Product Classification

INGREDIENTS (10)

HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
ROSUVASTATIN CALCIUMActive
Quantity: 40 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Anhydrous Dibasic Calcium PhosphateInactive
Code: L11K75P92J
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT

rosuvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69434-007
Application NumberANDA212059
Product Classification
M
Marketing Category
C73584
G
Generic Name
rosuvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 11, 2020
FDA Product Classification

INGREDIENTS (10)

ROSUVASTATIN CALCIUMActive
Quantity: 20 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
Anhydrous Dibasic Calcium PhosphateInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

rosuvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69434-005
Application NumberANDA212059
Product Classification
M
Marketing Category
C73584
G
Generic Name
rosuvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 11, 2020
FDA Product Classification

INGREDIENTS (10)

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
Anhydrous Dibasic Calcium PhosphateInactive
Code: L11K75P92J
Classification: IACT
CrospovidoneInactive
Code: 2S7830E561
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ROSUVASTATIN CALCIUMActive
Quantity: 5 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT

rosuvastatin calcium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69434-006
Application NumberANDA212059
Product Classification
M
Marketing Category
C73584
G
Generic Name
rosuvastatin calcium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 11, 2020
FDA Product Classification

INGREDIENTS (10)

LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ROSUVASTATIN CALCIUMActive
Quantity: 10 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
Anhydrous Dibasic Calcium PhosphateInactive
Code: L11K75P92J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT

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Rosuvastatin Calcium - FDA Drug Approval Details