FDA.reportPublic FDA data

Fluoxetine

Product NDC
50090-6081
11-digit product format
500906081
Labeler code
50090
Product ID
50090-6081_107069a9-db7c-4635-93f8-3d56fdf0399c
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
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
50090-6081-0Fluoxetine30 in 1 BOTTLECAPSULE303
50090-6081-1Fluoxetine60 in 1 BOTTLECAPSULE603
50090-6081-3Fluoxetine90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6081-0EA - Each50090-6081f807b63d-1702-4892-85a2-d6a64a0457ef12022-10-06
50090-6081-1EA - Each50090-60813b5762f6-3049-4c54-9e3b-695b496018cd12022-10-06
50090-6081-3EA - Each50090-6081cb0fcdbd-7961-4eaf-9c71-b91ef474b09512022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6081FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 3 package rows20231017_224c8c17-0183-4cd7-ab9e-0062f3c624f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310385FLUoxetine 20 MG Oral CapsulePSN224c8c17-0183-4cd7-ab9e-0062f3c624f03
310385fluoxetine 20 MG Oral CapsuleSCD224c8c17-0183-4cd7-ab9e-0062f3c624f03
310385fluoxetine 20 MG (as fluoxetine HCl 22.4 MG) Oral CapsuleSY224c8c17-0183-4cd7-ab9e-0062f3c624f03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6081-05009060810030 CAPSULE in 1 BOTTLE (50090-6081-0) 30 capsule2022-09-200000-00-00NoNoCurrent
50090-6081-15009060810160 CAPSULE in 1 BOTTLE (50090-6081-1) 60 capsule2022-09-200000-00-00NoNoCurrent
50090-6081-35009060810390 CAPSULE in 1 BOTTLE (50090-6081-3) 90 capsule2022-09-200000-00-00NoNoCurrent