FDA.reportPublic FDA data

Fluoxetine

Product NDC
50090-7225
11-digit product format
500907225
Labeler code
50090
Product ID
50090-7225_4046e69b-99c5-4e6a-88d5-65a47af87326
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
20 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 HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI9W7N6B1KJ
Rxcui310385

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
50090-7225-0Fluoxetine30 in 1 BOTTLECAPSULE308
50090-7225-1Fluoxetine60 in 1 BOTTLECAPSULE608
50090-7225-3Fluoxetine90 in 1 BOTTLECAPSULE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7225-0EA - Each50090-72255c68f455-858c-44ab-abd9-37ae9badfc3212024-09-09
50090-7225-1EA - Each50090-7225ba82fa55-63a9-48d6-b49b-dd4294d8500612024-09-09
50090-7225-3EA - Each50090-722532819a17-3851-49fd-84a8-42b7fbbc390612024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7225FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [A-S MEDICATION SOLUTIONS]6Current NDC, 3 package rows20240823_cca9edf9-2454-4bf9-98e8-c531a8f5dc42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSNcca9edf9-2454-4bf9-98e8-c531a8f5dc428
310385fluoxetine 20 MG Oral CapsuleSCDcca9edf9-2454-4bf9-98e8-c531a8f5dc428
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSYcca9edf9-2454-4bf9-98e8-c531a8f5dc428

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7225-05009072250030 CAPSULE in 1 BOTTLE (50090-7225-0) 30 capsule2024-08-20NoNoCurrent
50090-7225-15009072250160 CAPSULE in 1 BOTTLE (50090-7225-1) 60 capsule2024-08-20NoNoCurrent
50090-7225-35009072250390 CAPSULE in 1 BOTTLE (50090-7225-3) 90 capsule2024-08-20NoNoCurrent