Escitalopram

Orange BookUNIISPLATC N06AB10

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

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
6878874611
100 TABLET, FILM COATED in 1 BOTTLE (68788-7461-1)
ndc11
6878874613
30 TABLET, FILM COATED in 1 BOTTLE (68788-7461-3)
ndc11
6878874616
60 TABLET, FILM COATED in 1 BOTTLE (68788-7461-6)
ndc11
6878874618
28 TABLET, FILM COATED in 1 BOTTLE (68788-7461-8)
ndc11
6878874619
90 TABLET, FILM COATED in 1 BOTTLE (68788-7461-9)

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": "68788-7461_b578ecff-c411-4dfc-b7b0-0947577907ee",
  "productndc": "68788-7461",
  "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": "20120315",
  "active_numerator_strength": "20"
}

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