Basic Information
Prozac
0777-3104
Regulatory Information
0777-3104
NDA018936
C73594
December 23, 2021
USA
These highlights do not include all the information needed to use PROZAC safely and effectively. See full prescribing information for PROZAC. PROZAC (fluoxetine capsules) for oral use Initial U.S. Approval: 1987
HUMAN PRESCRIPTION DRUG LABEL
57
Company Information
024062718
Active Ingredients
Gelatin, Unspecified
Code: 2G86QN327L
Class Code: IACT
Sodium lauryl sulfate
Code: 368GB5141J
Class Code: IACT
Titanium dioxide
Code: 15FIX9V2JP
Class Code: IACT
Starch, Corn
Code: O8232NY3SJ
Class Code: IACT
FD&C Blue No. 1
Code: H3R47K3TBD
Class Code: IACT
Dimethicone
Code: 92RU3N3Y1O
Class Code: IACT
Ferric Oxide Yellow
Code: EX438O2MRT
Class Code: IACT
Benzyl Alcohol
Code: LKG8494WBH
Class Code: IACT
Methylparaben
Code: A2I8C7HI9T
Class Code: IACT
Butylparaben
Code: 3QPI1U3FV8
Class Code: IACT
Sodium Propionate
Code: DK6Y9P42IN
Class Code: IACT
Propylparaben
Code: Z8IX2SC1OH
Class Code: IACT
Carboxymethylcellulose
Code: 05JZI7B19X
Class Code: IACT
Active Moieties
Fluoxetine
Code: 01K63SUP8D