Varenicline
Varenicline Tablets
Approved
Approval ID
481b94af-ee34-44be-8ca1-b2415525efac
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 28, 2023
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Varenicline
PRODUCT DETAILS
NDC Product Code70771-1774
Application NumberANDA216723
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 28, 2023
Generic NameVarenicline
INGREDIENTS (11)
VARENICLINE TARTRATEActive
Quantity: 1 mg in 1 1
Code: 82269ASB48
Classification: ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 1 ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
Varenicline
PRODUCT DETAILS
NDC Product Code70771-1773
Application NumberANDA216723
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateSeptember 28, 2023
Generic NameVarenicline
INGREDIENTS (10)
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
VARENICLINE TARTRATEActive
Quantity: 0.5 mg in 1 1
Code: 82269ASB48
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT