Escitalopram Oxalate

Orange BookUNIISPLATC N06AB10

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

Identification

ManufacturerAmneal Pharmaceuticals LLC

CountryUS (United States)

ATC codeN06AB10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
6516202103
30 TABLET, FILM COATED in 1 BOTTLE (65162-021-03)
ndc11
6516202109
90 TABLET, FILM COATED in 1 BOTTLE (65162-021-09)
ndc11
6516202111
1000 TABLET, FILM COATED in 1 BOTTLE (65162-021-11)
ndc11
6516202150
500 TABLET, FILM COATED in 1 BOTTLE (65162-021-50)

Annotations

UNII (FDA Substance ID)

5U85DBW7LO

ESCITALOPRAM OXALATE

RxCUI 353108

Orange Book

A205619

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": "65162-021_058fe58a-fa86-459a-b79a-ac337913bc7e",
  "productndc": "65162-021",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "205619",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "May 17, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "May 17, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "003",
        "approval_date": "May 17, 2017"
      }
    ],
    "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": "ANDA205619",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Escitalopram Oxalate",
  "start_marketing_date": "20170517",
  "active_numerator_strength": "20"
}

Related drugs

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