sertraline hydrochloride

Generic: sertraline hydrochloride

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

Drug Facts

Product Profile

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

sertraline hydrochloride 25 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 84386-097
Product ID 84386-097_b497dfeb-a48c-4f2a-b309-b56f3a26a19b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077206
Listing Expiration 2026-12-31
Marketing Start 2025-11-20

Pharmacologic Class

Classes
cytochrome p450 2d6 inhibitors [moa] serotonin reuptake inhibitor [epc] serotonin uptake inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 84386097
Hyphenated Format 84386-097

Supplemental Identifiers

RxCUI
312938 312940 312941
UPC
0384386097015
UNII
UTI8907Y6X

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 sertraline hydrochloride (source: ndc)
Generic Name sertraline hydrochloride (source: ndc)
Application Number ANDA077206 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (84386-097-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (84386-097-05)
  • 30 TABLET, FILM COATED in 1 BOTTLE (84386-097-30)
  • 50 TABLET, FILM COATED in 1 BOTTLE (84386-097-50)
  • 5000 TABLET, FILM COATED in 1 BOTTLE (84386-097-51)
  • 60 TABLET, FILM COATED in 1 BOTTLE (84386-097-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (84386-097-90)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (84386-097-99)
source: ndc

Packages (8)

84386-097-01 100 TABLET, FILM COATED in 1 BOTTLE (84386-097-01) 84386-097-05 500 TABLET, FILM COATED in 1 BOTTLE (84386-097-05) 84386-097-30 30 TABLET, FILM COATED in 1 BOTTLE (84386-097-30) 84386-097-50 50 TABLET, FILM COATED in 1 BOTTLE (84386-097-50) 84386-097-51 5000 TABLET, FILM COATED in 1 BOTTLE (84386-097-51) 84386-097-60 60 TABLET, FILM COATED in 1 BOTTLE (84386-097-60) 84386-097-90 90 TABLET, FILM COATED in 1 BOTTLE (84386-097-90) 84386-097-99 1000 TABLET, FILM COATED in 1 BOTTLE (84386-097-99)

Ingredients (1)

sertraline hydrochloride (25 mg/1)

Linked Drug Pages (1)

Sertraline Hydrochloride ndc-match (0.9)

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"}