Esomeprazole Sodium

Orange BookUNIISPLATC A02BC05

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

Identification

ManufacturerGland Pharma Limited

CountryUS (United States)

ATC codeA02BC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6808345110
10 VIAL in 1 CARTON (68083-451-10) / 5 mL in 1 VIAL (68083-451-01)

Annotations

UNII (FDA Substance ID)

L2C9GWQ43H

ESOMEPRAZOLE SODIUM

RxCUI 1294569

Orange Book

A203349

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": "68083-451_e8d62781-b9de-4d02-b5d2-02b024895c95",
  "productndc": "68083-451",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "203349",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 20MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Apr 1, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 40MG BASE/VIAL",
        "product_no": "002",
        "approval_date": "Apr 1, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESOMEPRAZOLE SODIUM",
  "proprietary_name": "Esomeprazole Sodium",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA203349",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Esomeprazole Sodium",
  "start_marketing_date": "20200401",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code A02BC05.

Access this data programmatically

Query Esomeprazole Sodium and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs