Package 84386-105-01
Brand: fluoxetine
Generic: fluoxetinePackage Facts
Identity
Package NDC
84386-105-01
Digits Only
8438610501
Product NDC
84386-105
Description
100 TABLET, FILM COATED in 1 BOTTLE (84386-105-01)
Marketing
Marketing Status
Brand
fluoxetine
Generic
fluoxetine
Sample Package
No
Linked Drug Pages (1)
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"}