Fluoxetine

Product NDC
55700-866
11-digit product format
557000866
Labeler code
55700
Product ID
55700-866_161ed6e2-3324-4d17-a7a7-8a2c8f9a1145
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA204597
Marketing category
ANDA
Marketing start
2020-06-02
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
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-866-905570008669090 CAPSULE in 1 BOTTLE (55700-866-90) 90 capsule2020-06-020000-00-00NoNoCurrent