Prozac
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
Approved
Approval ID
c88f33ed-6dfb-4c5e-bc01-d8e36dd97299
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 18, 2023
Manufacturers
FDA
Dista Products Company
DUNS: 024062718
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluoxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0777-3105
Application NumberNDA018936
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fluoxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 23, 2021
FDA Product Classification
INGREDIENTS (14)
Fluoxetine hydrochlorideActive
Quantity: 20 mg in 1 1
Code: I9W7N6B1KJ
Classification: ACTIM
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Gelatin, UnspecifiedInactive
Code: 2G86QN327L
Classification: IACT
Sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
DimethiconeInactive
Code: 92RU3N3Y1O
Classification: IACT
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT
ButylparabenInactive
Code: 3QPI1U3FV8
Classification: IACT
MethylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
PropylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
Sodium PropionateInactive
Code: DK6Y9P42IN
Classification: IACT
CarboxymethylcelluloseInactive
Code: 05JZI7B19X
Classification: IACT
Fluoxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0777-3104
Application NumberNDA018936
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fluoxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 23, 2021
FDA Product Classification
INGREDIENTS (14)
Fluoxetine hydrochlorideActive
Quantity: 10 mg in 1 1
Code: I9W7N6B1KJ
Classification: ACTIM
Gelatin, UnspecifiedInactive
Code: 2G86QN327L
Classification: IACT
Sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
DimethiconeInactive
Code: 92RU3N3Y1O
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT
MethylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
ButylparabenInactive
Code: 3QPI1U3FV8
Classification: IACT
Sodium PropionateInactive
Code: DK6Y9P42IN
Classification: IACT
PropylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
CarboxymethylcelluloseInactive
Code: 05JZI7B19X
Classification: IACT
Fluoxetine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0777-3107
Application NumberNDA018936
Product Classification
M
Marketing Category
C73594
G
Generic Name
Fluoxetine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 23, 2021
FDA Product Classification
INGREDIENTS (9)
Fluoxetine hydrochlorideActive
Quantity: 40 mg in 1 1
Code: I9W7N6B1KJ
Classification: ACTIM
Gelatin, UnspecifiedInactive
Code: 2G86QN327L
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
DimethiconeInactive
Code: 92RU3N3Y1O
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT