Fluoxetine

Product NDC
55289-610
11-digit product format
552890610
Labeler code
55289
Product ID
55289-610_d2917d99-fd51-8e0f-e053-2a95a90ae747
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA075049
Marketing category
ANDA
Marketing start
2002-01-29
Marketing end
2022-10-31
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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-610-14EA - Each55289-610d5c432aa-dd69-47bd-94d7-92347384b77312012-07-24
55289-610-28EA - Each55289-610f10f141d-9254-435d-b883-be7d30cafe5d12012-07-24
55289-610-30EA - Each55289-6104a7306fd-c1ab-4b2d-8f17-508495c2b36612012-07-24
55289-610-60EA - Each55289-610ba9bc266-0734-402a-8d0d-51bbbc881c9512012-07-24
55289-610-90EA - Each55289-610d46729dc-8b55-4f58-b7e5-10ecf87de83f12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-610-145528906101414 CAPSULE in 1 BOTTLE, PLASTIC (55289-610-14) 14 capsule2011-10-132022-10-31NoNoCurrent
55289-610-285528906102828 CAPSULE in 1 BOTTLE, PLASTIC (55289-610-28) 28 capsule2011-10-132022-10-31NoNoCurrent
55289-610-305528906103030 CAPSULE in 1 BOTTLE, PLASTIC (55289-610-30) 30 capsule2011-10-132022-10-31NoNoCurrent
55289-610-605528906106060 CAPSULE in 1 BOTTLE, PLASTIC (55289-610-60) 60 capsule2011-10-132022-10-31NoNoCurrent
55289-610-905528906109090 CAPSULE in 1 BOTTLE, PLASTIC (55289-610-90) 90 capsule2017-04-262022-10-31NoNoCurrent