FDA.reportPublic FDA data

Fluoxetine

Product NDC
50090-6193
11-digit product format
500906193
Labeler code
50090
Product ID
50090-6193_ee346fc9-8b1a-4db4-830c-b1cdf30ec29f
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
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
50090-6193-0Fluoxetine30 in 1 BOTTLECAPSULE303
50090-6193-2Fluoxetine90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6193-0EA - Each50090-619326a80958-0189-4831-b700-6f89a285c4af12022-12-07
50090-6193-2EA - Each50090-6193665e9622-ff32-479c-b72c-2c3aec1cfbc112022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6193FLUOXETINE (FLUOXETINE HYDROCHLORIDE) CAPSULE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 2 package rows20231025_a408c325-d2d5-4e88-85ce-96913eb58183.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310384FLUoxetine 10 MG Oral CapsulePSNa408c325-d2d5-4e88-85ce-96913eb581833
310384fluoxetine 10 MG Oral CapsuleSCDa408c325-d2d5-4e88-85ce-96913eb581833
310384fluoxetine 10 MG (as fluoxetine HCl 11.2 MG) Oral CapsuleSYa408c325-d2d5-4e88-85ce-96913eb581833

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6193-05009061930030 CAPSULE in 1 BOTTLE (50090-6193-0) 30 capsule2022-10-310000-00-00NoNoCurrent
50090-6193-25009061930290 CAPSULE in 1 BOTTLE (50090-6193-2) 90 capsule2022-10-310000-00-00NoNoCurrent