FDA.reportPublic FDA data

Fluoxetine

Product NDC
63187-361
11-digit product format
631870361
Labeler code
63187
Product ID
63187-361_6b493581-ed1a-4346-9eab-0fce11fdb8ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204597
Marketing category
ANDA
Marketing start
2015-03-16
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
63187-361-30Fluoxetine30 in 1 BOTTLECAPSULE303
63187-361-60Fluoxetine60 in 1 BOTTLECAPSULE603
63187-361-90Fluoxetine90 in 1 BOTTLECAPSULE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-361FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20210115_a6457d6e-5586-40e9-883d-352ee0527d80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313989FLUoxetine 40 MG Oral CapsulePSNa6457d6e-5586-40e9-883d-352ee0527d803
313989fluoxetine 40 MG Oral CapsuleSCDa6457d6e-5586-40e9-883d-352ee0527d803
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSYa6457d6e-5586-40e9-883d-352ee0527d803

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-361-306318703613030 CAPSULE in 1 BOTTLE (63187-361-30) 30 capsule2016-08-010000-00-00NoNoCurrent
63187-361-606318703616060 CAPSULE in 1 BOTTLE (63187-361-60) 60 capsule2016-08-010000-00-00NoNoCurrent
63187-361-906318703619090 CAPSULE in 1 BOTTLE (63187-361-90) 90 capsule2016-08-010000-00-00NoNoCurrent