escitalopram

Generic: escitalopram

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

Drug Facts

Product Profile

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

escitalopram oxalate 20 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1465
Product ID 67046-1465_2d58aaca-22d8-7da2-e063-6394a90af047
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078777
Listing Expiration 2026-12-31
Marketing Start 2025-02-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461465
Hyphenated Format 67046-1465

Supplemental Identifiers

RxCUI
351250
UNII
5U85DBW7LO

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 escitalopram (source: ndc)
Generic Name escitalopram (source: ndc)
Application Number ANDA078777 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1465-3)
source: ndc

Packages (1)

Ingredients (1)

escitalopram oxalate (20 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "2d58aaca-22d8-7da2-e063-6394a90af047", "openfda": {"unii": ["5U85DBW7LO"], "rxcui": ["351250"], "spl_set_id": ["2d58c448-4a6c-1b7d-e063-6294a90a7d03"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1465-3)", "package_ndc": "67046-1465-3", "marketing_start_date": "20250204"}], "brand_name": "escitalopram", "product_id": "67046-1465_2d58aaca-22d8-7da2-e063-6394a90af047", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "67046-1465", "generic_name": "escitalopram", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "escitalopram", "active_ingredients": [{"name": "ESCITALOPRAM OXALATE", "strength": "20 mg/1"}], "application_number": "ANDA078777", "marketing_category": "ANDA", "marketing_start_date": "20250204", "listing_expiration_date": "20261231"}