escitalopram oxalate

Generic: escitalopram

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

Drug Facts

Product Profile

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

escitalopram oxalate 10 mg/1

Manufacturer
Exelan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 76282-250
Product ID 76282-250_787c121b-d227-4f2f-aa8d-e2dd69790fa6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078604
Listing Expiration 2026-12-31
Marketing Start 2012-10-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76282250
Hyphenated Format 76282-250

Supplemental Identifiers

RxCUI
349332 351249 351250
UPC
0376282251103 0376282250908 0376282250304 0376282249100 0376282251301 0376282251905 0376282249902 0376282249308
UNII
5U85DBW7LO

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 escitalopram oxalate (source: ndc)
Generic Name escitalopram (source: ndc)
Application Number ANDA078604 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (76282-250-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (76282-250-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (76282-250-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (76282-250-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76282-250-90)
source: ndc

Packages (5)

76282-250-01 100 TABLET, FILM COATED in 1 BOTTLE (76282-250-01) 76282-250-05 500 TABLET, FILM COATED in 1 BOTTLE (76282-250-05) 76282-250-10 1000 TABLET, FILM COATED in 1 BOTTLE (76282-250-10) 76282-250-30 30 TABLET, FILM COATED in 1 BOTTLE (76282-250-30) 76282-250-90 90 TABLET, FILM COATED in 1 BOTTLE (76282-250-90)

Ingredients (1)

escitalopram oxalate (10 mg/1)

Linked Drug Pages (1)

Escitalopram oxalate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "787c121b-d227-4f2f-aa8d-e2dd69790fa6", "openfda": {"upc": ["0376282251103", "0376282250908", "0376282250304", "0376282249100", "0376282251301", "0376282251905", "0376282249902", "0376282249308"], "unii": ["5U85DBW7LO"], "rxcui": ["349332", "351249", "351250"], "spl_set_id": ["8a3f4bc9-cd6e-49b1-ab6c-982b70f51fd2"], "manufacturer_name": ["Exelan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (76282-250-01)", "package_ndc": "76282-250-01", "marketing_start_date": "20121001"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (76282-250-05)", "package_ndc": "76282-250-05", "marketing_start_date": "20121001"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (76282-250-10)", "package_ndc": "76282-250-10", "marketing_start_date": "20121001"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76282-250-30)", "package_ndc": "76282-250-30", "marketing_start_date": "20121001"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76282-250-90)", "package_ndc": "76282-250-90", "marketing_start_date": "20121001"}], "brand_name": "Escitalopram oxalate", "product_id": "76282-250_787c121b-d227-4f2f-aa8d-e2dd69790fa6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "76282-250", "generic_name": "escitalopram", "labeler_name": "Exelan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Escitalopram oxalate", "active_ingredients": [{"name": "ESCITALOPRAM OXALATE", "strength": "10 mg/1"}], "application_number": "ANDA078604", "marketing_category": "ANDA", "marketing_start_date": "20121001", "listing_expiration_date": "20261231"}