Fluoxetine

Product NDC

55700-654

11-digit product format

557000654

Labeler code

55700

Product ID

55700-654_17ddcdd1-c4e3-46db-a23b-18ea86218a1e

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Fluoxetine Hydrochloride

Dosage form

CAPSULE

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA204597

Marketing category

ANDA

Marketing start

2018-07-13

Marketing end

0000-00-00

Substance

FLUOXETINE HYDROCHLORIDE

Active strength

40 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