fluoxetine

Generic: fluoxetine hydrochloride

Labeler: couplerllc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine hydrochloride
Labeler couplerllc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 40 mg/1

Manufacturer
CouplerLLC

Identifiers & Regulatory

Product NDC 67046-1580
Product ID 67046-1580_3e111b48-7c02-ee3b-e063-6394a90a5499
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078619
Listing Expiration 2026-12-31
Marketing Start 2025-09-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461580
Hyphenated Format 67046-1580

Supplemental Identifiers

RxCUI
313989
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 ANDA078619 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BLISTER PACK (67046-1580-3)
source: ndc

Packages (1)

67046-1580-3 30 CAPSULE in 1 BLISTER PACK (67046-1580-3)

Ingredients (1)

fluoxetine hydrochloride (40 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": "3e111b48-7c02-ee3b-e063-6394a90a5499", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["313989"], "spl_set_id": ["3e111be4-28f0-c290-e063-6294a90a447f"], "manufacturer_name": ["CouplerLLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (67046-1580-3)", "package_ndc": "67046-1580-3", "marketing_start_date": "20250905"}], "brand_name": "Fluoxetine", "product_id": "67046-1580_3e111b48-7c02-ee3b-e063-6394a90a5499", "dosage_form": "CAPSULE", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "67046-1580", "generic_name": "Fluoxetine Hydrochloride", "labeler_name": "CouplerLLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "40 mg/1"}], "application_number": "ANDA078619", "marketing_category": "ANDA", "marketing_start_date": "20250905", "listing_expiration_date": "20261231"}