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United States · US · US:80425-0375_14077a5d-dd96-3661-e063-6294a90a484a

Escitalopram

Orange BookUNIISPLATC N06AB10

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

Identification

ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC
CountryUS (United States)
ATC codeN06AB10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8042503751
    30 TABLET, FILM COATED in 1 BOTTLE (80425-0375-1)
  • ndc11
    8042503752
    60 TABLET, FILM COATED in 1 BOTTLE (80425-0375-2)
  • ndc11
    8042503753
    90 TABLET, FILM COATED in 1 BOTTLE (80425-0375-3)

Annotations

UNII (FDA Substance ID)
5U85DBW7LO
ESCITALOPRAM OXALATE
RxCUI 353108
Orange Book
A090432
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": "80425-0375_14077a5d-dd96-3661-e063-6294a90a484a",
  "productndc": "80425-0375",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090432",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Sep 11, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Sep 11, 2012"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "003",
        "approval_date": "Sep 11, 2012"
      }
    ],
    "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": "ANDA090432",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Escitalopram Oxalate",
  "start_marketing_date": "20240313",
  "active_numerator_strength": "10"
}

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