ESCITALOPRAM OXALATE

Orange BookUNIISPLATC N06AB10

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

Identification

ManufacturerAscent Pharmaceuticals, Inc

CountryUS (United States)

ATC codeN06AB10

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
4360247410
1000 TABLET in 1 BOTTLE (43602-474-10)
ndc11
4360247430
30 TABLET in 1 BOTTLE (43602-474-30)

Annotations

UNII (FDA Substance ID)

5U85DBW7LO

ESCITALOPRAM OXALATE

RxCUI 353108

Orange Book

A215177

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": "43602-474_c891ea0b-ed9d-4e75-a529-2b8a651034d2",
  "productndc": "43602-474",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "215177",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE",
        "product_no": "001",
        "approval_date": "Jul 15, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 10MG BASE",
        "product_no": "002",
        "approval_date": "Jul 15, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "003",
        "approval_date": "Jul 15, 2025"
      }
    ],
    "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": "ANDA215177",
  "marketing_category": "ANDA",
  "nonproprietary_name": "escitalopram",
  "start_marketing_date": "20250715",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code N06AB10.

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