escitalopram oxalate

Generic: escitalopram oxalate

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name escitalopram oxalate
Generic Name escitalopram oxalate
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

escitalopram oxalate 5 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-019
Product ID 53746-019_fe4fad91-a1c2-41f2-933d-94bdfb86d38c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205619
Listing Expiration 2026-12-31
Marketing Start 2017-05-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53746019
Hyphenated Format 53746-019

Supplemental Identifiers

RxCUI
349332 351249 351250
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 oxalate (source: ndc)
Application Number ANDA205619 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 500 TABLET, FILM COATED in 1 BOTTLE (53746-019-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (53746-019-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (53746-019-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (53746-019-90)
source: ndc

Packages (4)

53746-019-05 500 TABLET, FILM COATED in 1 BOTTLE (53746-019-05) 53746-019-10 1000 TABLET, FILM COATED in 1 BOTTLE (53746-019-10) 53746-019-30 30 TABLET, FILM COATED in 1 BOTTLE (53746-019-30) 53746-019-90 90 TABLET, FILM COATED in 1 BOTTLE (53746-019-90)

Ingredients (1)

escitalopram oxalate (5 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": "fe4fad91-a1c2-41f2-933d-94bdfb86d38c", "openfda": {"unii": ["5U85DBW7LO"], "rxcui": ["349332", "351249", "351250"], "spl_set_id": ["4f941d7a-5abb-4907-a7a1-480245deef87"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (53746-019-05)", "package_ndc": "53746-019-05", "marketing_start_date": "20170517"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (53746-019-10)", "package_ndc": "53746-019-10", "marketing_start_date": "20170517"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (53746-019-30)", "package_ndc": "53746-019-30", "marketing_start_date": "20170517"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (53746-019-90)", "package_ndc": "53746-019-90", "marketing_start_date": "20170517"}], "brand_name": "Escitalopram Oxalate", "product_id": "53746-019_fe4fad91-a1c2-41f2-933d-94bdfb86d38c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "53746-019", "generic_name": "Escitalopram Oxalate", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Escitalopram Oxalate", "active_ingredients": [{"name": "ESCITALOPRAM OXALATE", "strength": "5 mg/1"}], "application_number": "ANDA205619", "marketing_category": "ANDA", "marketing_start_date": "20170517", "listing_expiration_date": "20261231"}