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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1774
Application NumberANDA216723
Product Classification
M
Marketing Category
C73584
G
Generic Name
Varenicline
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1773
Application NumberANDA216723
Product Classification
M
Marketing Category
C73584
G
Generic Name
Varenicline
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2023
FDA Product Classification
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