Package 84386-097-51
Brand: sertraline hydrochloride
Generic: sertraline hydrochloridePackage Facts
Identity
Package NDC
84386-097-51
Digits Only
8438609751
Product NDC
84386-097
Description
5000 TABLET, FILM COATED in 1 BOTTLE (84386-097-51)
Marketing
Marketing Status
Brand
sertraline hydrochloride
Generic
sertraline hydrochloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "b497dfeb-a48c-4f2a-b309-b56f3a26a19b", "openfda": {"upc": ["0384386097015"], "unii": ["UTI8907Y6X"], "rxcui": ["312938", "312940", "312941"], "spl_set_id": ["b497dfeb-a48c-4f2a-b309-b56f3a26a19b"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (84386-097-01)", "package_ndc": "84386-097-01", "marketing_start_date": "20251120"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (84386-097-05)", "package_ndc": "84386-097-05", "marketing_start_date": "20251120"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (84386-097-30)", "package_ndc": "84386-097-30", "marketing_start_date": "20251120"}, {"sample": false, "description": "50 TABLET, FILM COATED in 1 BOTTLE (84386-097-50)", "package_ndc": "84386-097-50", "marketing_start_date": "20251120"}, {"sample": false, "description": "5000 TABLET, FILM COATED in 1 BOTTLE (84386-097-51)", "package_ndc": "84386-097-51", "marketing_start_date": "20251120"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (84386-097-60)", "package_ndc": "84386-097-60", "marketing_start_date": "20251120"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (84386-097-90)", "package_ndc": "84386-097-90", "marketing_start_date": "20251120"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (84386-097-99)", "package_ndc": "84386-097-99", "marketing_start_date": "20251120"}], "brand_name": "Sertraline Hydrochloride", "product_id": "84386-097_b497dfeb-a48c-4f2a-b309-b56f3a26a19b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "84386-097", "generic_name": "Sertraline Hydrochloride", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sertraline Hydrochloride", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA077206", "marketing_category": "ANDA", "marketing_start_date": "20251120", "listing_expiration_date": "20261231"}