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varenicline tartrate

These highlights do not include all the information needed to use VARENICLINE TABLETS safely and effectively. See full prescribing information for VARENICLINE TABLETS . VARENICLINE tablets, for oral use Initial U.S. Approval: 2006

Approved
Approval ID

16ee0a83-88d7-97de-1e07-f9e6dcb5c934

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 31, 2025

Manufacturers
FDA

Dr. Reddys Laboratories Inc.

DUNS: 802315887

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

varenicline tartrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43598-907
Application NumberANDA215931
Product Classification
M
Marketing Category
C73584
G
Generic Name
varenicline tartrate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2025
FDA Product Classification

INGREDIENTS (11)

Varenicline TartrateActive
Quantity: 0.5 mg in 1 1
Code: 82269ASB48
Classification: ACTIM
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT

varenicline tartrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43598-908
Application NumberANDA215931
Product Classification
M
Marketing Category
C73584
G
Generic Name
varenicline tartrate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2025
FDA Product Classification

INGREDIENTS (11)

FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Varenicline TartrateActive
Quantity: 1 mg in 1 1
Code: 82269ASB48
Classification: ACTIM
Microcrystalline CelluloseInactive
Code: OP1R32D61U
Classification: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT

varenicline tartrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43598-022
Application NumberANDA215931
Product Classification
M
Marketing Category
C73584
G
Generic Name
varenicline tartrate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2025
FDA Product Classification

varenicline tartrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code43598-023
Application NumberANDA215931
Product Classification
M
Marketing Category
C73584
G
Generic Name
varenicline tartrate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2025
FDA Product Classification

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varenicline tartrate - FDA Drug Approval Details