escitalopram

Generic: escitalopram

Labeler: quality care products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name escitalopram
Generic Name escitalopram
Labeler quality care products, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

escitalopram oxalate 10 mg/1

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 83008-065
Product ID 83008-065_8167ad51-fca0-476b-82d7-ca5f131114a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078777
Marketing Start 2024-06-25
Marketing End 2026-04-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83008065
Hyphenated Format 83008-065

Supplemental Identifiers

RxCUI
349332
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 ANDA078777 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (83008-065-90)
source: ndc

Packages (1)

83008-065-90 90 TABLET, FILM COATED in 1 BOTTLE (83008-065-90)

Ingredients (1)

escitalopram oxalate (10 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": "8167ad51-fca0-476b-82d7-ca5f131114a7", "openfda": {"unii": ["5U85DBW7LO"], "rxcui": ["349332"], "spl_set_id": ["9802fe84-45ef-4486-ad4c-6965c1d3bb94"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (83008-065-90)", "package_ndc": "83008-065-90", "marketing_end_date": "20260408", "marketing_start_date": "20240625"}], "brand_name": "escitalopram", "product_id": "83008-065_8167ad51-fca0-476b-82d7-ca5f131114a7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "83008-065", "generic_name": "escitalopram", "labeler_name": "Quality Care Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "escitalopram", "active_ingredients": [{"name": "ESCITALOPRAM OXALATE", "strength": "10 mg/1"}], "application_number": "ANDA078777", "marketing_category": "ANDA", "marketing_end_date": "20260408", "marketing_start_date": "20240625"}