escitalopram oxalate

Generic: escitalopram

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

Drug Facts

Product Profile

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

escitalopram oxalate 5 mg/1

Manufacturer
Cipla USA Inc.

Identifiers & Regulatory

Product NDC 69097-847
Product ID 69097-847_7e44336f-9692-42ff-af45-f98edd0c803c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078604
Listing Expiration 2026-12-31
Marketing Start 2016-06-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69097847
Hyphenated Format 69097-847

Supplemental Identifiers

RxCUI
349332 351249 351250
UPC
0369097847050 0369097848057
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
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (69097-847-02)
  • 90 TABLET, FILM COATED in 1 BOTTLE (69097-847-05)
  • 100 TABLET, FILM COATED in 1 BOTTLE (69097-847-07)
  • 500 TABLET, FILM COATED in 1 BOTTLE (69097-847-12)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (69097-847-15)
source: ndc

Packages (5)

69097-847-02 30 TABLET, FILM COATED in 1 BOTTLE (69097-847-02) 69097-847-05 90 TABLET, FILM COATED in 1 BOTTLE (69097-847-05) 69097-847-07 100 TABLET, FILM COATED in 1 BOTTLE (69097-847-07) 69097-847-12 500 TABLET, FILM COATED in 1 BOTTLE (69097-847-12) 69097-847-15 1000 TABLET, FILM COATED in 1 BOTTLE (69097-847-15)

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": "7e44336f-9692-42ff-af45-f98edd0c803c", "openfda": {"upc": ["0369097847050", "0369097848057"], "unii": ["5U85DBW7LO"], "rxcui": ["349332", "351249", "351250"], "spl_set_id": ["31ce0b82-58fe-44f3-8887-c55d8df1b773"], "manufacturer_name": ["Cipla USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (69097-847-02)", "package_ndc": "69097-847-02", "marketing_start_date": "20160616"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (69097-847-05)", "package_ndc": "69097-847-05", "marketing_start_date": "20160616"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (69097-847-07)", "package_ndc": "69097-847-07", "marketing_start_date": "20160616"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (69097-847-12)", "package_ndc": "69097-847-12", "marketing_start_date": "20160616"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (69097-847-15)", "package_ndc": "69097-847-15", "marketing_start_date": "20160616"}], "brand_name": "Escitalopram Oxalate", "product_id": "69097-847_7e44336f-9692-42ff-af45-f98edd0c803c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "69097-847", "generic_name": "Escitalopram", "labeler_name": "Cipla USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Escitalopram Oxalate", "active_ingredients": [{"name": "ESCITALOPRAM OXALATE", "strength": "5 mg/1"}], "application_number": "ANDA078604", "marketing_category": "ANDA", "marketing_start_date": "20160616", "listing_expiration_date": "20261231"}