FDA.reportPublic FDA data

Fluoxetine

Product NDC
49884-468
11-digit product format
498840468
Labeler code
49884
Product ID
49884-468_ea0f9b50-185b-4a12-824e-3a7628aa0906
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA209419
Marketing category
ANDA
Marketing start
2017-11-16
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluoxetine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUOXETINE HYDROCHLORIDE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui1190110

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce7d40ce-bfb8-ee15-a060-423ec90d7ac9Product name620250331
e5b459e3-ddce-4802-aab4-2c901d71ae85Product name520250129
6d3d5b3a-d6b8-8417-8428-6414b08f1464Product name320240130
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
e7177a8f-11de-ee90-ca22-068e6ef54cf5Product name420230104
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
82da1192-6e97-fa73-2f85-6a50c10b4704Product name320161212
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-468-11Fluoxetine30 in 1 BOTTLETABLET, FILM COATED309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-468-11EA - Each49884-468af996b64-f370-4e66-950b-dc041fd5d35812017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-468FLUOXETINE TABLET, FILM COATED [ENDO USA, INC.]9Current NDC, Legacy NDC, 1 package rows20250112_6fff3732-efc3-4cbd-a8fa-cde3181f03e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190110FLUoxetine HCl 60 MG Oral TabletPSN10293946-5a06-4c21-9f78-941be360b09b104
1190110fluoxetine 60 MG Oral TabletSCD10293946-5a06-4c21-9f78-941be360b09b104
1190110fluoxetine (as fluoxetine HCl) 60 MG Oral TabletSY10293946-5a06-4c21-9f78-941be360b09b104
1190110FLUoxetine HCl 60 MG Oral TabletPSNdced86a0-fc08-465c-897c-f8899e6206d5103
1190110fluoxetine 60 MG Oral TabletSCDdced86a0-fc08-465c-897c-f8899e6206d5103
1190110fluoxetine (as fluoxetine HCl) 60 MG Oral TabletSYdced86a0-fc08-465c-897c-f8899e6206d5103
1190110FLUoxetine HCl 60 MG Oral TabletPSN6fff3732-efc3-4cbd-a8fa-cde3181f03e69
1190110fluoxetine 60 MG Oral TabletSCD6fff3732-efc3-4cbd-a8fa-cde3181f03e69
1190110fluoxetine (as fluoxetine HCl) 60 MG Oral TabletSY6fff3732-efc3-4cbd-a8fa-cde3181f03e69

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49884-468-114988404681130 TABLET, FILM COATED in 1 BOTTLE (49884-468-11) 2017-11-160000-00-00NoNoCurrent