fluoxetine

Generic: fluoxetine

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler endo usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 60 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 49884-468
Product ID 49884-468_ea0f9b50-185b-4a12-824e-3a7628aa0906
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209419
Listing Expiration 2026-12-31
Marketing Start 2017-11-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49884468
Hyphenated Format 49884-468

Supplemental Identifiers

RxCUI
1190110
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 (source: ndc)
Application Number ANDA209419 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 60 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (49884-468-11)
source: ndc

Packages (1)

49884-468-11 30 TABLET, FILM COATED in 1 BOTTLE (49884-468-11)

Ingredients (1)

fluoxetine hydrochloride (60 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": "ea0f9b50-185b-4a12-824e-3a7628aa0906", "openfda": {"unii": ["I9W7N6B1KJ"], "rxcui": ["1190110"], "spl_set_id": ["6fff3732-efc3-4cbd-a8fa-cde3181f03e6"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (49884-468-11)", "package_ndc": "49884-468-11", "marketing_start_date": "20171116"}], "brand_name": "Fluoxetine", "product_id": "49884-468_ea0f9b50-185b-4a12-824e-3a7628aa0906", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "49884-468", "generic_name": "Fluoxetine", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "60 mg/1"}], "application_number": "ANDA209419", "marketing_category": "ANDA", "marketing_start_date": "20171116", "listing_expiration_date": "20261231"}