escitalopram

Generic: escitalopram

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name escitalopram
Generic Name escitalopram
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

escitalopram oxalate 10 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8569
Product ID 68788-8569_3cb153dc-e977-4848-868a-bce458631a2a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078777
Listing Expiration 2026-12-31
Marketing Start 2024-01-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888569
Hyphenated Format 68788-8569

Supplemental Identifiers

RxCUI
349332
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
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (68788-8569-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8569-3)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8569-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8569-9)
source: ndc

Packages (4)

68788-8569-1 100 TABLET, FILM COATED in 1 BOTTLE (68788-8569-1) 68788-8569-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8569-3) 68788-8569-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8569-6) 68788-8569-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8569-9)

Ingredients (1)

escitalopram oxalate (10 mg/1)

Linked Drug Pages (1)

escitalopram ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3cb153dc-e977-4848-868a-bce458631a2a", "openfda": {"unii": ["5U85DBW7LO"], "rxcui": ["349332"], "spl_set_id": ["d16a7510-c787-4c9b-818b-1ffbcc62b3c3"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (68788-8569-1)", "package_ndc": "68788-8569-1", "marketing_start_date": "20250408"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8569-3)", "package_ndc": "68788-8569-3", "marketing_start_date": "20240123"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8569-6)", "package_ndc": "68788-8569-6", "marketing_start_date": "20250408"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8569-9)", "package_ndc": "68788-8569-9", "marketing_start_date": "20250408"}], "brand_name": "escitalopram", "product_id": "68788-8569_3cb153dc-e977-4848-868a-bce458631a2a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "68788-8569", "generic_name": "escitalopram", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "escitalopram", "active_ingredients": [{"name": "ESCITALOPRAM OXALATE", "strength": "10 mg/1"}], "application_number": "ANDA078777", "marketing_category": "ANDA", "marketing_start_date": "20240123", "listing_expiration_date": "20261231"}