escitalopram oxalate

Generic: escitalopram oxalate

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name escitalopram oxalate
Generic Name escitalopram oxalate
Labeler macleods pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

escitalopram oxalate 10 mg/21

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-037
Product ID 33342-037_53210109-53db-4d08-8ea4-be60e5597caf
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202210
Listing Expiration 2026-12-31
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 33342037
Hyphenated Format 33342-037

Supplemental Identifiers

RxCUI
349332 351249 351250
UPC
0333342036155 0333342037152 0333342037114 0333342038159 0333342038111 0333342036117
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 ANDA202210 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/21
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (33342-037-11)
  • 100 TABLET, FILM COATED in 1 CARTON (33342-037-12)
  • 500 TABLET, FILM COATED in 1 BOTTLE (33342-037-15)
source: ndc

Packages (3)

33342-037-11 100 TABLET, FILM COATED in 1 BOTTLE (33342-037-11) 33342-037-12 100 TABLET, FILM COATED in 1 CARTON (33342-037-12) 33342-037-15 500 TABLET, FILM COATED in 1 BOTTLE (33342-037-15)

Ingredients (1)

escitalopram oxalate (10 mg/21)

Linked Drug Pages (1)

Escitalopram Oxalate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "53210109-53db-4d08-8ea4-be60e5597caf", "openfda": {"upc": ["0333342036155", "0333342037152", "0333342037114", "0333342038159", "0333342038111", "0333342036117"], "unii": ["5U85DBW7LO"], "rxcui": ["349332", "351249", "351250"], "spl_set_id": ["24b43cb4-1a26-44a2-b1d8-a40239eb5c7c"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (33342-037-11)", "package_ndc": "33342-037-11", "marketing_start_date": "20120911"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 CARTON (33342-037-12)", "package_ndc": "33342-037-12", "marketing_start_date": "20120911"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (33342-037-15)", "package_ndc": "33342-037-15", "marketing_start_date": "20150909"}], "brand_name": "Escitalopram Oxalate", "product_id": "33342-037_53210109-53db-4d08-8ea4-be60e5597caf", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "33342-037", "generic_name": "Escitalopram Oxalate", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Escitalopram Oxalate", "active_ingredients": [{"name": "ESCITALOPRAM OXALATE", "strength": "10 mg/21"}], "application_number": "ANDA202210", "marketing_category": "ANDA", "marketing_start_date": "20120911", "listing_expiration_date": "20261231"}