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United States · US · US:76282-250_787c121b-d227-4f2f-aa8d-e2dd69790fa6

Escitalopram oxalate

Orange BookUNIISPLATC N06AB10

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

Identification

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

Packs · 5

  • ndc11
    7628225001
    100 TABLET, FILM COATED in 1 BOTTLE (76282-250-01)
  • ndc11
    7628225005
    500 TABLET, FILM COATED in 1 BOTTLE (76282-250-05)
  • ndc11
    7628225010
    1000 TABLET, FILM COATED in 1 BOTTLE (76282-250-10)
  • ndc11
    7628225030
    30 TABLET, FILM COATED in 1 BOTTLE (76282-250-30)
  • ndc11
    7628225090
    90 TABLET, FILM COATED in 1 BOTTLE (76282-250-90)

Annotations

UNII (FDA Substance ID)
5U85DBW7LO
ESCITALOPRAM OXALATE
RxCUI 353108
Orange Book
A078604
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": "76282-250_787c121b-d227-4f2f-aa8d-e2dd69790fa6",
  "productndc": "76282-250",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078604",
    "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": "ANDA078604",
  "marketing_category": "ANDA",
  "nonproprietary_name": "escitalopram",
  "start_marketing_date": "20121001",
  "active_numerator_strength": "10"
}

Related drugs

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