Rosuvastatin Calcium
These highlights do not include all the information needed to use ROSUVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN CALCIUM TABLETS. ROSUVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 2003
Approved
Approval ID
606d16fb-82e4-420d-9456-09997562b528
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 30, 2023
Manufacturers
FDA
Tris Pharma Inc
DUNS: 947472119
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 Code27808-155
Application NumberANDA207408
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2023
FDA Product Classification
INGREDIENTS (9)
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ROSUVASTATIN CALCIUMActive
Quantity: 5 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
Rosuvastatin Calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27808-156
Application NumberANDA207408
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2023
FDA Product Classification
INGREDIENTS (9)
ROSUVASTATIN CALCIUMActive
Quantity: 10 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Rosuvastatin Calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27808-157
Application NumberANDA207408
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2023
FDA Product Classification
INGREDIENTS (9)
ROSUVASTATIN CALCIUMActive
Quantity: 20 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Rosuvastatin Calcium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27808-158
Application NumberANDA207408
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin Calcium
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2023
FDA Product Classification
INGREDIENTS (9)
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
ROSUVASTATIN CALCIUMActive
Quantity: 40 mg in 1 1
Code: 83MVU38M7Q
Classification: ACTIM
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYPROMELLOSE 2208 (100 MPA.S)Inactive
Code: B1QE5P712K
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT