FDA.reportPublic FDA data

Fluoxetine

Product NDC
50090-6702
11-digit product format
500906702
Labeler code
50090
Product ID
50090-6702_57eb3004-f630-4418-a421-c235024c74b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluoxetine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204597
Marketing category
ANDA
Marketing start
2019-09-25
Substance
FLUOXETINE HYDROCHLORIDE
Active strength
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui310384

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
50090-6702-0Fluoxetine30 in 1 BOTTLECAPSULE301
50090-6702-2Fluoxetine90 in 1 BOTTLECAPSULE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6702FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [A-S MEDICATION SOLUTIONS]1Current NDC, 2 package rows20231002_c4eeae3d-ae56-4e7e-b07d-02851f12039f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSNc4eeae3d-ae56-4e7e-b07d-02851f12039f1
310384fluoxetine 10 MG Oral CapsuleSCDc4eeae3d-ae56-4e7e-b07d-02851f12039f1
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYc4eeae3d-ae56-4e7e-b07d-02851f12039f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-6702-05009067020030 CAPSULE in 1 BOTTLE (50090-6702-0) 30 capsule2023-09-25NoNoCurrent
50090-6702-25009067020290 CAPSULE in 1 BOTTLE (50090-6702-2) 90 capsule2023-09-25NoNoCurrent