ATORVASTATIN CALCIUM
These highlights do not include all the information needed to use atorvastatin calcium safely and effectively. See full prescribing information for atorvastatin calcium tablets. ATORVASTATIN calcium tablets for oral use Initial U.S. Approval: 19 9 6
Approved
Approval ID
64abfa40-e0ab-46ae-8c7c-7c199b89b7c1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 17, 2018
Manufacturers
FDA
Marlex Pharmaceuticals Inc
DUNS: 782540215
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ATORVASTATIN CALCIUM
PRODUCT DETAILS
NDC Product Code10135-653
Application NumberANDA205519
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 12, 2018
Generic NameATORVASTATIN CALCIUM
INGREDIENTS (15)
ATORVASTATIN CALCIUMActive
Quantity: 80 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
COPOVIDONEInactive
Code: D9C330MD8B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
ATORVASTATIN CALCIUM
PRODUCT DETAILS
NDC Product Code10135-651
Application NumberANDA205519
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 12, 2018
Generic NameATORVASTATIN CALCIUM
INGREDIENTS (16)
ATORVASTATIN CALCIUMActive
Quantity: 40 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIM
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
COPOVIDONEInactive
Code: D9C330MD8B
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
EGG PHOSPHOLIPIDSInactive
Code: 1Z74184RGV
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ATORVASTATIN CALCIUM
PRODUCT DETAILS
NDC Product Code10135-650
Application NumberANDA205519
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 12, 2018
Generic NameATORVASTATIN CALCIUM
INGREDIENTS (16)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
ATORVASTATIN CALCIUMActive
Quantity: 20 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
EGG PHOSPHOLIPIDSInactive
Code: 1Z74184RGV
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
COPOVIDONEInactive
Code: D9C330MD8B
Classification: IACT
ATORVASTATIN CALCIUM
PRODUCT DETAILS
NDC Product Code10135-649
Application NumberANDA205519
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 12, 2018
Generic NameATORVASTATIN CALCIUM
INGREDIENTS (16)
ATORVASTATIN CALCIUMActive
Quantity: 10 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
COPOVIDONEInactive
Code: D9C330MD8B
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM CARBONATEInactive
Code: 45P3261C7T
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
EGG PHOSPHOLIPIDSInactive
Code: 1Z74184RGV
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT