Rosuvastatin
ROSUVASTATIN TABLETS. 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 use Initial U.S. Approval: 2003
Approved
Approval ID
0f02c184-49f3-8fa6-e063-6394a90a5092
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 15, 2024
Manufacturers
FDA
Golden State Medical Supply, Inc.
DUNS: 603184490
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Rosuvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-851
Application NumberANDA206381
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 15, 2024
FDA Product Classification
INGREDIENTS (10)
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
ROSUVASTATINActive
Quantity: 40 mg in 1 1
Code: 413KH5ZJ73
Classification: ACTIB
Rosuvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-849
Application NumberANDA206381
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 15, 2024
FDA Product Classification
INGREDIENTS (10)
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
ROSUVASTATINActive
Quantity: 10 mg in 1 1
Code: 413KH5ZJ73
Classification: ACTIB
Rosuvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-848
Application NumberANDA206381
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 15, 2024
FDA Product Classification
INGREDIENTS (10)
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ROSUVASTATINActive
Quantity: 5 mg in 1 1
Code: 413KH5ZJ73
Classification: ACTIB
Rosuvastatin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-850
Application NumberANDA206381
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rosuvastatin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 15, 2024
FDA Product Classification
INGREDIENTS (10)
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ROSUVASTATINActive
Quantity: 20 mg in 1 1
Code: 413KH5ZJ73
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT