Escitalopram

Orange BookUNIISPLATC N06AB10

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

Identification

ManufacturerAsclemed USA, Inc.

CountryUS (United States)

ATC codeN06AB10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
7642072101
100 TABLET, FILM COATED in 1 BOTTLE (76420-721-01)
ndc11
7642072105
500 TABLET, FILM COATED in 1 BOTTLE (76420-721-05)
ndc11
7642072110
10 TABLET, FILM COATED in 1 BOTTLE (76420-721-10)
ndc11
7642072130
30 TABLET, FILM COATED in 1 BOTTLE (76420-721-30)
ndc11
7642072160
60 TABLET, FILM COATED in 1 BOTTLE (76420-721-60)
ndc11
7642072190
90 TABLET, FILM COATED in 1 BOTTLE (76420-721-90)

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": "76420-721_4ac15baa-6fcc-476b-e063-6294a90a2a89",
  "productndc": "76420-721",
  "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": "20120911",
  "active_numerator_strength": "5"
}

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