sertraline hydrochloride

Generic: sertraline hydrochloride

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sertraline hydrochloride
Generic Name sertraline hydrochloride
Labeler coupler llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sertraline hydrochloride 50 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1483
Product ID 67046-1483_2ce04fcc-4bad-22dc-e063-6294a90af8a9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078403
Listing Expiration 2026-12-31
Marketing Start 2025-01-29

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 670461483
Hyphenated Format 67046-1483

Supplemental Identifiers

RxCUI
312941
UNII
UTI8907Y6X

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 ANDA078403 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1483-3)
source: ndc

Packages (1)

67046-1483-3 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1483-3)

Ingredients (1)

sertraline hydrochloride (50 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": "2ce04fcc-4bad-22dc-e063-6294a90af8a9", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["312941"], "spl_set_id": ["2ce05049-030f-3e8b-e063-6394a90a4885"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1483-3)", "package_ndc": "67046-1483-3", "marketing_start_date": "20250129"}], "brand_name": "Sertraline hydrochloride", "product_id": "67046-1483_2ce04fcc-4bad-22dc-e063-6294a90af8a9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "67046-1483", "generic_name": "Sertraline hydrochloride", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sertraline hydrochloride", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA078403", "marketing_category": "ANDA", "marketing_start_date": "20250129", "listing_expiration_date": "20261231"}