Basic Information
Saxagliptin
65862-825
Regulatory Information
65862-825
ANDA205972
C73584
January 9, 2024
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 use Initial U.S. Approval: 2009
Human Prescription Drug Label
2
Company Information
650082092
Active Ingredients
ASCORBIC ACID
Code: PQ6CK8PD0R
Class Code: IACT
GLYCERYL MONOSTEARATE
Code: 230OU9XXE4
Class Code: IACT
CROSPOVIDONE (35 .MU.M)
Code: 40UAA97IT9
Class Code: IACT
HYDROXYPROPYL CELLULOSE (45000 WAMW)
Code: 8VAB711C5E
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
MANNITOL
Code: 3OWL53L36A
Class Code: IACT
MICROCRYSTALLINE CELLULOSE 301
Code: W7YXH6D4BD
Class Code: IACT
POLYVINYL ALCOHOL, UNSPECIFIED
Code: 532B59J990
Class Code: IACT
MICROCRYSTALLINE CELLULOSE 102
Code: PNR0YF693Y
Class Code: IACT
SODIUM LAURYL SULFATE
Code: 368GB5141J
Class Code: IACT
FD&C YELLOW NO. 5
Code: I753WB2F1M
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
FERROSOFERRIC OXIDE
Code: XM0M87F357
Class Code: IACT
Active Moieties
SAXAGLIPTIN ANHYDROUS
Code: 8I7IO46IVQ