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United States · US · US:68001-592_3f619ebc-6f45-5959-e063-6294a90a61af

Escitalopram

Orange BookUNIISPLATC N06AB10

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerBluePoint Laboratories
CountryUS (United States)
ATC codeN06AB10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6800159200
    100 TABLET, FILM COATED in 1 BOTTLE (68001-592-00)
  • ndc11
    6800159208
    1000 TABLET, FILM COATED in 1 BOTTLE (68001-592-08)

Annotations

UNII (FDA Substance ID)
5U85DBW7LO
ESCITALOPRAM OXALATE
RxCUI 353108
Orange Book
A078032
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "5U85DBW7LO",
    "rxcui": "353108",
    "inchikey": "KTGRHKOEFSJQNS-BDQAORGHSA-N",
    "display_name": "ESCITALOPRAM OXALATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "43eb9e4f-1a46-46f7-9e9d-43e866963b37": {
      "match": "brand_token",
      "title": "ESCITALOPRAM TABLET, FILM COATED [BRYANT RANCH PREPACK]",
      "spl_version": "104",
      "published_date": "2026-06-01"
    }
  },
  "productid": "68001-592_3f619ebc-6f45-5959-e063-6294a90a61af",
  "productndc": "68001-592",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078032",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Aug 28, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Aug 28, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "003",
        "approval_date": "Aug 28, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESCITALOPRAM OXALATE",
  "proprietary_name": "Escitalopram",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078032",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Escitalopram",
  "start_marketing_date": "20231214",
  "active_numerator_strength": "10"
}

Related drugs

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