escitalopram

Generic: escitalopram

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name escitalopram
Generic Name escitalopram
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

escitalopram oxalate 20 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-425
Product ID 71610-425_09b866f0-4435-4d1a-9cc7-c6a5ea487cb0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202389
Listing Expiration 2026-12-31
Marketing Start 2013-03-21

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610425
Hyphenated Format 71610-425

Supplemental Identifiers

RxCUI
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 (source: ndc)
Application Number ANDA202389 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (71610-425-60)
source: ndc

Packages (1)

71610-425-60 90 TABLET, FILM COATED in 1 BOTTLE (71610-425-60)

Ingredients (1)

escitalopram oxalate (20 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": "09b866f0-4435-4d1a-9cc7-c6a5ea487cb0", "openfda": {"unii": ["5U85DBW7LO"], "rxcui": ["351250"], "spl_set_id": ["85b2f57e-53f3-4b93-9128-ad74cc34be4c"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (71610-425-60)", "package_ndc": "71610-425-60", "marketing_start_date": "20200508"}], "brand_name": "Escitalopram", "product_id": "71610-425_09b866f0-4435-4d1a-9cc7-c6a5ea487cb0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "71610-425", "generic_name": "Escitalopram", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Escitalopram", "active_ingredients": [{"name": "ESCITALOPRAM OXALATE", "strength": "20 mg/1"}], "application_number": "ANDA202389", "marketing_category": "ANDA", "marketing_start_date": "20130321", "listing_expiration_date": "20261231"}