escitalopram

Generic: escitalopram oxalate

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name escitalopram
Generic Name escitalopram oxalate
Labeler asclemed usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

escitalopram oxalate 5 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-721
Product ID 76420-721_4ac15baa-6fcc-476b-e063-6294a90a2a89
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090432
Listing Expiration 2027-12-31
Marketing Start 2012-09-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420721
Hyphenated Format 76420-721

Supplemental Identifiers

RxCUI
349332 351249 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 oxalate (source: ndc)
Application Number ANDA090432 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (76420-721-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (76420-721-05)
  • 10 TABLET, FILM COATED in 1 BOTTLE (76420-721-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (76420-721-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (76420-721-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76420-721-90)
source: ndc

Packages (6)

76420-721-01 100 TABLET, FILM COATED in 1 BOTTLE (76420-721-01) 76420-721-05 500 TABLET, FILM COATED in 1 BOTTLE (76420-721-05) 76420-721-10 10 TABLET, FILM COATED in 1 BOTTLE (76420-721-10) 76420-721-30 30 TABLET, FILM COATED in 1 BOTTLE (76420-721-30) 76420-721-60 60 TABLET, FILM COATED in 1 BOTTLE (76420-721-60) 76420-721-90 90 TABLET, FILM COATED in 1 BOTTLE (76420-721-90)

Ingredients (1)

escitalopram oxalate (5 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": "4ac15baa-6fcc-476b-e063-6294a90a2a89", "openfda": {"unii": ["5U85DBW7LO"], "rxcui": ["349332", "351249", "351250"], "spl_set_id": ["2957a003-7714-4e16-aeca-623fd6c5d702"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (76420-721-01)", "package_ndc": "76420-721-01", "marketing_start_date": "20240506"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (76420-721-05)", "package_ndc": "76420-721-05", "marketing_start_date": "20240506"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (76420-721-10)", "package_ndc": "76420-721-10", "marketing_start_date": "20240506"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76420-721-30)", "package_ndc": "76420-721-30", "marketing_start_date": "20240506"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (76420-721-60)", "package_ndc": "76420-721-60", "marketing_start_date": "20240506"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76420-721-90)", "package_ndc": "76420-721-90", "marketing_start_date": "20240506"}], "brand_name": "Escitalopram", "product_id": "76420-721_4ac15baa-6fcc-476b-e063-6294a90a2a89", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "76420-721", "generic_name": "Escitalopram Oxalate", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Escitalopram", "active_ingredients": [{"name": "ESCITALOPRAM OXALATE", "strength": "5 mg/1"}], "application_number": "ANDA090432", "marketing_category": "ANDA", "marketing_start_date": "20120911", "listing_expiration_date": "20271231"}