fluoxetine

Generic: fluoxetine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fluoxetine
Generic Name fluoxetine
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fluoxetine hydrochloride 20 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 84386-105
Product ID 84386-105_09fb3100-1e06-4cdc-8016-7e4f5d097490
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213286
Listing Expiration 2027-12-31
Marketing Start 2026-01-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84386105
Hyphenated Format 84386-105

Supplemental Identifiers

RxCUI
248642 313990
UPC
0384386104300
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 ANDA213286 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (84386-105-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (84386-105-30)
source: ndc

Packages (2)

84386-105-01 100 TABLET, FILM COATED in 1 BOTTLE (84386-105-01) 84386-105-30 30 TABLET, FILM COATED in 1 BOTTLE (84386-105-30)

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": "09fb3100-1e06-4cdc-8016-7e4f5d097490", "openfda": {"upc": ["0384386104300"], "unii": ["I9W7N6B1KJ"], "rxcui": ["248642", "313990"], "spl_set_id": ["09fb3100-1e06-4cdc-8016-7e4f5d097490"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (84386-105-01)", "package_ndc": "84386-105-01", "marketing_start_date": "20260115"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (84386-105-30)", "package_ndc": "84386-105-30", "marketing_start_date": "20260115"}], "brand_name": "Fluoxetine", "product_id": "84386-105_09fb3100-1e06-4cdc-8016-7e4f5d097490", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "84386-105", "generic_name": "Fluoxetine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fluoxetine", "active_ingredients": [{"name": "FLUOXETINE HYDROCHLORIDE", "strength": "20 mg/1"}], "application_number": "ANDA213286", "marketing_category": "ANDA", "marketing_start_date": "20260115", "listing_expiration_date": "20271231"}