FDA.reportPublic FDA data

Fluoxetine

Product NDC
50228-421
11-digit product format
502280421
Labeler code
50228
Product ID
50228-421_08a26093-1715-5580-e063-6294a90a4ff6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ScieGen Pharmaceuticals, Inc
Application
ANDA210935
Marketing category
ANDA
Marketing start
2019-03-20
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
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 HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui248642, 313990

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
50228-421-01Fluoxetine100 in 1 BOTTLETABLET, FILM COATED1004
50228-421-10Fluoxetine1000 in 1 BOTTLETABLET, FILM COATED10004
50228-421-30Fluoxetine30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50228-421-01EA - Each50228-421bd263cb7-74ae-4f0d-a7dc-b7803d886b5212019-05-02
50228-421-30EA - Each50228-4215724f3ca-13a5-490d-af9a-7f244bd1c2a012019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50228-421FLUOXETINE TABLET, FILM COATED [SCIEGEN PHARMACEUTICALS, INC]4Current NDC, Legacy NDC, 3 package rows20231027_b5035f61-693e-4386-8a07-3c36a6a46917.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248642FLUoxetine 20 MG Oral TabletPSNb5035f61-693e-4386-8a07-3c36a6a469174
313990FLUoxetine HCl 10 MG Oral TabletPSNb5035f61-693e-4386-8a07-3c36a6a469174
313990fluoxetine 10 MG Oral TabletSCDb5035f61-693e-4386-8a07-3c36a6a469174
248642fluoxetine 20 MG Oral TabletSCDb5035f61-693e-4386-8a07-3c36a6a469174
313990fluoxetine 10 MG (as fluoxetine hydrochloride 11.2 MG) Oral TabletSYb5035f61-693e-4386-8a07-3c36a6a469174
248642fluoxetine 20 MG (as fluoxetine hydrochloride 22.4 MG) Oral TabletSYb5035f61-693e-4386-8a07-3c36a6a469174

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50228-421-0150228042101100 TABLET, FILM COATED in 1 BOTTLE (50228-421-01) 2019-03-200000-00-00NoNoCurrent
50228-421-10502280421101000 TABLET, FILM COATED in 1 BOTTLE (50228-421-10) 2019-03-200000-00-00NoNoCurrent
50228-421-305022804213030 TABLET, FILM COATED in 1 BOTTLE (50228-421-30) 2019-03-200000-00-00NoNoCurrent