FDA.reportPublic FDA data

Fluoxetine

Product NDC
50228-422
11-digit product format
502280422
Labeler code
50228
Product ID
50228-422_2c27d964-db05-c709-e063-6294a90a385c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FLUOXETINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc.
Application
ANDA211282
Marketing category
ANDA
Marketing start
2019-01-10
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
e7177a8f-11de-ee90-ca22-068e6ef54cf5Product name420230104
82da1192-6e97-fa73-2f85-6a50c10b4704Product name320161212
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50228-422-10Fluoxetine1000 in 1 BOTTLETABLET10006
50228-422-30Fluoxetine30 in 1 BOTTLETABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-422FLUOXETINE (FLUOXETINE HYDROCHLORIDE) TABLET [SCIEGEN PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 2 package rows20250121_a7ba9184-7dad-4f82-a947-bb2cc6b760ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1190110FLUoxetine HCl 60 MG Oral TabletPSNa7ba9184-7dad-4f82-a947-bb2cc6b760ce6
1190110fluoxetine 60 MG Oral TabletSCDa7ba9184-7dad-4f82-a947-bb2cc6b760ce6
1190110fluoxetine (as fluoxetine HCl) 60 MG Oral TabletSYa7ba9184-7dad-4f82-a947-bb2cc6b760ce6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50228-422-10502280422101000 TABLET in 1 BOTTLE (50228-422-10) 1000 tablet2019-01-100000-00-00NoNoCurrent
50228-422-305022804223030 TABLET in 1 BOTTLE (50228-422-30) 30 tablet2019-01-100000-00-00NoNoCurrent