fluoxetine

Generic: fluoxetine hydrochloride

Labeler: lannett company, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine hydrochloride
Labeler lannett company, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/5mL

Manufacturer
Lannett Company, Inc.

Identifiers & Regulatory

Product NDC 54838-523
Product ID 54838-523_bda5665d-4bcd-4426-9397-e438485d0d29
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077849
Listing Expiration 2026-12-31
Marketing Start 2009-08-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54838523
Hyphenated Format 54838-523

Supplemental Identifiers

RxCUI
310386
UPC
0354838523409
UNII
I9W7N6B1KJ

Packaging Origin

Original Packager
true

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 ANDA077849 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/5mL
source: ndc
Packaging
  • 120 mL in 1 BOTTLE, PLASTIC (54838-523-40)
source: ndc

Packages (1)

54838-523-40 120 mL in 1 BOTTLE, PLASTIC (54838-523-40)

Ingredients (1)

fluoxetine hydrochloride (20 mg/5mL)

Linked Drug Pages (1)

Fluoxetine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "bda5665d-4bcd-4426-9397-e438485d0d29", "openfda": {"upc": ["0354838523409"], "unii": ["I9W7N6B1KJ"], "rxcui": ["310386"], "spl_set_id": ["c856d72f-4a1a-4f75-ae54-c4ac83ddcfa1"], "manufacturer_name": ["Lannett Company, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "120 mL in 1 BOTTLE, PLASTIC (54838-523-40)", "package_ndc": "54838-523-40", "marketing_start_date": "20090827"}], "brand_name": "Fluoxetine", "product_id": "54838-523_bda5665d-4bcd-4426-9397-e438485d0d29", "dosage_form": "LIQUID", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "54838-523", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "Lannett Company, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/5mL"}], "application_number": "ANDA077849", "marketing_category": "ANDA", "marketing_start_date": "20090827", "listing_expiration_date": "20261231"}