Basic Information
Fluoxetine
63187-218
Regulatory Information
63187-218
ANDA075872
C73584
October 1, 2022
USA
These highlights do not include all the information needed to use fluoxetine tablets USP safely and effectively. See full prescribing information for fluoxetine tablets USP.FLUOXETINE tablets USP for oral useInitial U.S. Approval: 1987
HUMAN PRESCRIPTION DRUG LABEL
4
Company Information
079196022
Active Ingredients
D&C YELLOW NO. 10
Code: 35SW5USQ3G
Class Code: IACT
FD&C BLUE NO. 2
Code: L06K8R7DQK
Class Code: IACT
ALUMINUM OXIDE
Code: LMI26O6933
Class Code: IACT
FD&C YELLOW NO. 6
Code: H77VEI93A8
Class Code: IACT
HYPROMELLOSE 2910 (5 MPA.S)
Code: R75537T0T4
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
TALC
Code: 7SEV7J4R1U
Class Code: IACT
POVIDONE K30
Code: U725QWY32X
Class Code: IACT
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
INDIGOTINDISULFONATE SODIUM
Code: D3741U8K7L
Class Code: IACT
POLYETHYLENE GLYCOL 6000
Code: 30IQX730WE
Class Code: IACT
POLYETHYLENE GLYCOL 8000
Code: Q662QK8M3B
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
Active Moieties
FLUOXETINE
Code: 01K63SUP8D