Basic Information
Azithromycin Dihydrate
68071-2775
Regulatory Information
68071-2775
ANDA208249
C73584
September 9, 2022
USA
These highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
HUMAN PRESCRIPTION DRUG LABEL
2
Company Information
010632300
Active Ingredients
CROSCARMELLOSE SODIUM
Code: M28OL1HH48
Class Code: IACT
LECITHIN, SOYBEAN
Code: 1DI56QDM62
Class Code: IACT
FD&C RED NO. 40
Code: WZB9127XOA
Class Code: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
Code: L11K75P92J
Class Code: IACT
FD&C BLUE NO. 1
Code: H3R47K3TBD
Class Code: IACT
FD&C YELLOW NO. 6
Code: H77VEI93A8
Class Code: IACT
POLYETHYLENE GLYCOL 3350
Code: G2M7P15E5P
Class Code: IACT
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
POLYVINYL ALCOHOL, UNSPECIFIED
Code: 532B59J990
Class Code: IACT
Active Moieties
AZITHROMYCIN ANHYDROUS
Code: J2KLZ20U1M