Basic Information
SAXAGLIPTIN
68462-726
Regulatory Information
68462-726
ANDA205994
C73584
August 1, 2023
USA
These highlights do not include all the information needed to use SAXAGLIPTIN TABLETS safely and effectively. See full prescribing information for SAXAGLIPTIN TABLETS. SAXAGLIPTIN tablets, for oral useInitial U.S. Approval: 2009
HUMAN PRESCRIPTION DRUG LABEL
1
Company Information
130597813
Active Ingredients
CROSCARMELLOSE SODIUM
Code: M28OL1HH48
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
AMMONIA
Code: 5138Q19F1X
Class Code: IACT
BUTYL ALCOHOL
Code: 8PJ61P6TS3
Class Code: IACT
ISOPROPYL ALCOHOL
Code: ND2M416302
Class Code: IACT
FD&C BLUE NO. 2
Code: L06K8R7DQK
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
Active Moieties
saxagliptin anhydrous
Code: 8I7IO46IVQ