FDA.reportPublic FDA data

Fluoxetine

Product NDC
50090-6064
11-digit product format
500906064
Labeler code
50090
Product ID
50090-6064_11f98b1a-3393-4484-970b-3437c958a5e4
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
Rxcui313989

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
50090-6064-0Fluoxetine30 in 1 BOTTLECAPSULE303
50090-6064-1Fluoxetine90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6064-0EA - Each50090-60644d2e8da4-9131-4919-b91f-3b06c99b075312022-10-06
50090-6064-1EA - Each50090-606417fda014-0475-43b6-9731-0e9594380a8b12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6064FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 2 package rows20231118_3fba8d68-0663-4053-93ee-7531246fd47d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313989FLUoxetine 40 MG Oral CapsulePSN3fba8d68-0663-4053-93ee-7531246fd47d3
313989fluoxetine 40 MG Oral CapsuleSCD3fba8d68-0663-4053-93ee-7531246fd47d3
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY3fba8d68-0663-4053-93ee-7531246fd47d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6064-05009060640030 CAPSULE in 1 BOTTLE (50090-6064-0) 30 capsule2022-09-090000-00-00NoNoCurrent
50090-6064-15009060640190 CAPSULE in 1 BOTTLE (50090-6064-1) 90 capsule2022-09-090000-00-00NoNoCurrent