FDA.reportPublic FDA data

Fluoxetine

Product NDC
50090-5678
11-digit product format
500905678
Labeler code
50090
Product ID
50090-5678_f0824ffa-a9b8-479b-be51-6ce96681f676
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
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluoxetine
Listing expiration
2027-12-31

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
50090-5678-0Fluoxetine30 in 1 BOTTLECAPSULE308
50090-5678-1Fluoxetine90 in 1 BOTTLECAPSULE908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5678FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20231025_2c56a437-f6bf-4ac8-b1d9-fc8a605a97e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313989FLUoxetine 40 MG Oral CapsulePSN2c56a437-f6bf-4ac8-b1d9-fc8a605a97e78
313989fluoxetine 40 MG Oral CapsuleSCD2c56a437-f6bf-4ac8-b1d9-fc8a605a97e78
313989fluoxetine 40 MG (as fluoxetine HCl 44.8 MG) Oral CapsuleSY2c56a437-f6bf-4ac8-b1d9-fc8a605a97e78

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5678-05009056780030 CAPSULE in 1 BOTTLE (50090-5678-0) 30 capsule2021-09-210000-00-00NoNoCurrent
50090-5678-15009056780190 CAPSULE in 1 BOTTLE (50090-5678-1) 90 capsule2021-09-210000-00-00NoNoCurrent