Fluoxetine

Product NDC
70518-2162
11-digit product format
705182162
Labeler code
70518
Product ID
70518-2162_8cc323c1-1fd0-36e0-e053-2a95a90a2c69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fluoxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075755
Marketing category
ANDA
Marketing start
2019-06-27
Marketing end
0000-00-00
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
20 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