fluoxetine

Generic: fluoxetine hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine hydrochloride
Labeler a-s medication solutions
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-7225
Product ID 50090-7225_4046e69b-99c5-4e6a-88d5-65a47af87326
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204597
Listing Expiration 2026-12-31
Marketing Start 2015-03-16

Pharmacologic Class

Classes
serotonin reuptake inhibitor [epc] serotonin uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500907225
Hyphenated Format 50090-7225

Supplemental Identifiers

RxCUI
310385
UNII
I9W7N6B1KJ

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fluoxetine (source: ndc)
Generic Name fluoxetine hydrochloride (source: ndc)
Application Number ANDA204597 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BOTTLE (50090-7225-0)
  • 60 CAPSULE in 1 BOTTLE (50090-7225-1)
  • 90 CAPSULE in 1 BOTTLE (50090-7225-3)
source: ndc

Packages (3)

50090-7225-0 30 CAPSULE in 1 BOTTLE (50090-7225-0) 50090-7225-1 60 CAPSULE in 1 BOTTLE (50090-7225-1) 50090-7225-3 90 CAPSULE in 1 BOTTLE (50090-7225-3)

Ingredients (1)

fluoxetine hydrochloride (20 mg/1)

Linked Drug Pages (1)

Fluoxetine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4046e69b-99c5-4e6a-88d5-65a47af87326", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["310385"], "spl_set_id": ["cca9edf9-2454-4bf9-98e8-c531a8f5dc42"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BOTTLE (50090-7225-0)", "package_ndc": "50090-7225-0", "marketing_start_date": "20240820"}, {"sample": false, "description": "60 CAPSULE in 1 BOTTLE (50090-7225-1)", "package_ndc": "50090-7225-1", "marketing_start_date": "20240820"}, {"sample": false, "description": "90 CAPSULE in 1 BOTTLE (50090-7225-3)", "package_ndc": "50090-7225-3", "marketing_start_date": "20240820"}], "brand_name": "Fluoxetine", "product_id": "50090-7225_4046e69b-99c5-4e6a-88d5-65a47af87326", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "50090-7225", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA204597", "marketing_category": "ANDA", "marketing_start_date": "20150316", "listing_expiration_date": "20261231"}