Esomeprazole magnesium

Orange BookUNIISPLATC A02BC05

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

Identification

ManufacturerCipla USA Inc.

CountryUS (United States)

ATC codeA02BC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6909752834
30 FOR SUSPENSION in 1 CARTON (69097-528-34)

Annotations

UNII (FDA Substance ID)

36H71644EQ

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

RxCUI 1601995

Orange Book

A211751

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "36H71644EQ",
    "rxcui": "1601995",
    "inchikey": "DBOUSUONOXEWHU-VCKZSRROSA-N",
    "display_name": "ESOMEPRAZOLE MAGNESIUM DIHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "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": "69097-528_e64d9eeb-1821-4520-9325-8b006fec057f",
  "productndc": "69097-528",
  "dosage_form": "FOR SUSPENSION",
  "orange_book": {
    "appl_no": "211751",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE/PACKET",
        "product_no": "001",
        "approval_date": "Mar 23, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE/PACKET",
        "product_no": "002",
        "approval_date": "Mar 23, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESOMEPRAZOLE MAGNESIUM DIHYDRATE",
  "proprietary_name": "Esomeprazole magnesium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA211751",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Esomeprazole magnesium",
  "start_marketing_date": "20200324",
  "active_numerator_strength": "20"
}

Related drugs

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