Fluoxetine

Product NDC

70518-0971

11-digit product format

705180971

Labeler code

70518

Product ID

70518-0971_8f70068c-101a-3713-e053-2a95a90a9e93

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

fluoxetine

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

REMEDYREPACK INC.

Application

ANDA075755

Marketing category

ANDA

Marketing start

2018-01-22

Marketing end

0000-00-00

Substance

FLUOXETINE HYDROCHLORIDE

Active strength

10 mg/1

Pharmacologic classes

Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record