Atorvastatin Calcium
These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS. ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
Approved
Approval ID
67e60880-091a-4df7-8696-6e6c42a490e2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2024
Manufacturers
FDA
Ascend Laboratories, LLC
DUNS: 141250469
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 Code67877-513
Application NumberANDA209288
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 21, 2023
Generic NameAtorvastatin Calcium
INGREDIENTS (12)
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
ATORVASTATIN CALCIUM TRIHYDRATEActive
Quantity: 40 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIM
Atorvastatin Calcium
PRODUCT DETAILS
NDC Product Code67877-514
Application NumberANDA209288
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 21, 2023
Generic NameAtorvastatin Calcium
INGREDIENTS (12)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ATORVASTATIN CALCIUM TRIHYDRATEActive
Quantity: 80 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIM
Atorvastatin Calcium
PRODUCT DETAILS
NDC Product Code67877-512
Application NumberANDA209288
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 21, 2023
Generic NameAtorvastatin Calcium
INGREDIENTS (12)
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ATORVASTATIN CALCIUM TRIHYDRATEActive
Quantity: 20 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIM
Atorvastatin Calcium
PRODUCT DETAILS
NDC Product Code67877-511
Application NumberANDA209288
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 21, 2023
Generic NameAtorvastatin Calcium
INGREDIENTS (12)
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
ATORVASTATIN CALCIUM TRIHYDRATEActive
Quantity: 10 mg in 1 1
Code: 48A5M73Z4Q
Classification: ACTIM