Esomeprazole Sodium

Orange BookUNIISPLATC A02BC05

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

Identification

ManufacturerEugia US LLC

CountryUS (United States)

ATC codeA02BC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5515018505
10 VIAL in 1 CARTON (55150-185-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Annotations

UNII (FDA Substance ID)

L2C9GWQ43H

ESOMEPRAZOLE SODIUM

RxCUI 1294569

Orange Book

A204657

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "L2C9GWQ43H",
    "rxcui": "1294569",
    "inchikey": "RYXPMWYHEBGTRV-JIDHJSLPSA-N",
    "display_name": "ESOMEPRAZOLE SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "6a21f085-b60b-49b7-8098-99ccdc43dde3": {
      "match": "brand_token",
      "title": "ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE 20 MG (OTC) CAPSULE, DELAYED RELEASE ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE 20 MG MINI CAPSULE, DELAYED RELEASE [MARKSANS PHARMA LIMITED]",
      "spl_version": "3",
      "published_date": "2026-06-02"
    }
  },
  "productid": "55150-185_0f4cf0d6-61e7-429c-8658-e885e3c09b4a",
  "productndc": "55150-185",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "204657",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 20MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Aug 10, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 40MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Aug 10, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESOMEPRAZOLE SODIUM",
  "proprietary_name": "Esomeprazole Sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA204657",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Esomeprazole Sodium",
  "start_marketing_date": "20160810",
  "active_numerator_strength": "40"
}

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