FDA.reportPublic FDA data

Fluoxetine

Product NDC
50090-2589
11-digit product format
500902589
Labeler code
50090
Product ID
50090-2589_2343e8ec-e077-483b-a010-ff8bcc1d0a99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078619
Marketing category
ANDA
Marketing start
2008-01-31
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
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 HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui310385, 313989

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2589-02023-02-07C16284748780-1f386c64a-45c7-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987
50090-2589-12023-02-07C16284748780-1f386c64a-45c7-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987
50090-2589-02023-01-30C16284748780-1f386c64a-45c7-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987
50090-2589-12023-01-30C16284748780-1f386c64a-45c7-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use FLUOXETINE CAPSULES safely and effectively. See full prescribing information for FLUOXETINE CAPSULES. FLUOXETINE capsules, for oral use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2589-0Fluoxetine30 in 1 BOTTLECAPSULE3025
50090-2589-1Fluoxetine90 in 1 BOTTLECAPSULE9025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2589-0EA - Each50090-2589bd7d6f3f-8247-43ed-a160-d6b0d575c92c12019-04-11
50090-2589-1EA - Each50090-2589f4deb86b-f446-4f61-9db8-abdf161ac9c612019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2589FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [A-S MEDICATION SOLUTIONS]25Current NDC, Legacy NDC, 2 package rows20241010_42c4c341-8282-4961-8581-8a0430162559.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSN42c4c341-8282-4961-8581-8a043016255925
313989FLUoxetine 40 MG Oral CapsulePSN42c4c341-8282-4961-8581-8a043016255925
310385fluoxetine 20 MG Oral CapsuleSCD42c4c341-8282-4961-8581-8a043016255925
313989fluoxetine 40 MG Oral CapsuleSCD42c4c341-8282-4961-8581-8a043016255925
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY42c4c341-8282-4961-8581-8a043016255925
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY42c4c341-8282-4961-8581-8a043016255925

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2589-05009025890030 CAPSULE in 1 BOTTLE (50090-2589-0) 30 capsule2017-02-010000-00-00NoNoCurrent
50090-2589-15009025890190 CAPSULE in 1 BOTTLE (50090-2589-1) 90 capsule2016-11-020000-00-00NoNoCurrent