Fluoxetine

Product NDC
0093-5262
11-digit product format
000935262
Labeler code
0093
Product ID
0093-5262_c0117f32-94da-4719-baa3-e2087ec4319a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA211051
Marketing category
ANDA
Marketing start
2018-12-13
Marketing end
0000-00-00
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5262-56EA - Each0093-5262bb45005c-d798-4a15-a29c-302aaae436f712019-01-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-5262-560009352625630 TABLET, FILM COATED in 1 BOTTLE (0093-5262-56) 2018-12-130000-00-00NoNoCurrent