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United States · US · US:68788-8371_773ce75a-485e-41b5-b32d-336ab849dcbc

escitalopram oxalate

Orange BookUNIISPLATC N06AB10

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeN06AB10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    6878883711
    100 TABLET, FILM COATED in 1 BOTTLE (68788-8371-1)
  • ndc11
    6878883713
    30 TABLET, FILM COATED in 1 BOTTLE (68788-8371-3)
  • ndc11
    6878883716
    60 TABLET, FILM COATED in 1 BOTTLE (68788-8371-6)
  • ndc11
    6878883718
    28 TABLET, FILM COATED in 1 BOTTLE (68788-8371-8)
  • ndc11
    6878883719
    90 TABLET, FILM COATED in 1 BOTTLE (68788-8371-9)

Annotations

UNII (FDA Substance ID)
5U85DBW7LO
ESCITALOPRAM OXALATE
RxCUI 353108
Orange Book
A090939
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": "68788-8371_773ce75a-485e-41b5-b32d-336ab849dcbc",
  "productndc": "68788-8371",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090939",
    "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 oxalate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090939",
  "marketing_category": "ANDA",
  "nonproprietary_name": "escitalopram oxalate",
  "start_marketing_date": "20230201",
  "active_numerator_strength": "10"
}

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