Fluoxetine Hydrochloride

Product NDC
0781-2824
11-digit product format
007812824
Labeler code
0781
Product ID
0781-2824_1c89f15b-eefd-4be2-9055-1374a76669cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA075049
Marketing category
ANDA
Marketing start
2002-01-29
Marketing end
2022-10-31
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
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
0781-2824-01EA - Each0781-282448bc91e3-bdc8-406e-ae65-230b8f29538112012-07-24
0781-2824-10EA - Each0781-2824fa75981d-7514-486e-b7bf-664c3bdf612112012-07-24
0781-2824-31EA - Each0781-282408cee815-b848-4976-ba3c-77f6c5cb09fb12012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-2824-0100781282401100 CAPSULE in 1 BOTTLE (0781-2824-01) 100 capsule2002-01-292022-09-30NoNoCurrent
0781-2824-10007812824101000 CAPSULE in 1 BOTTLE (0781-2824-10) 1000 capsule2002-01-292022-10-31NoNoCurrent
0781-2824-310078128243130 CAPSULE in 1 BOTTLE (0781-2824-31) 30 capsule2002-01-292022-05-31NoNoCurrent