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United States · US · US:52427-795_4caf6d36-950a-522b-5914-079783778c6f

escitalopram

Orange BookUNIISPLATC N06AB10

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

Identification

ManufacturerAlmatica Pharma LLC
CountryUS (United States)
ATC codeN06AB10
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5242779530
    30 CAPSULE in 1 BOTTLE (52427-795-30)

Annotations

UNII (FDA Substance ID)
5U85DBW7LO
ESCITALOPRAM OXALATE
RxCUI 353108
Orange Book
N219130
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": "52427-795_4caf6d36-950a-522b-5914-079783778c6f",
  "productndc": "52427-795",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "219130",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 15MG BASE",
        "product_no": "001",
        "approval_date": "Aug 29, 2025"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESCITALOPRAM OXALATE",
  "proprietary_name": "escitalopram",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA219130",
  "marketing_category": "NDA",
  "nonproprietary_name": "escitalopram",
  "start_marketing_date": "20251006",
  "active_numerator_strength": "15"
}

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