Esomeprazole Magnesium

Orange BookUNIISPLATC A02BC05

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeA02BC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5965180530
30 GRANULE, DELAYED RELEASE in 1 CARTON (59651-805-30)

Annotations

UNII (FDA Substance ID)

R6DXU4WAY9

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

RxCUI 283562

Orange Book

A218948

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "R6DXU4WAY9",
    "rxcui": "283562",
    "inchikey": "VEVZQDGATGBLIC-OXLUMUBXSA-N",
    "display_name": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE",
    "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": "59651-805_e691b51e-2e31-4408-81c4-5afec6f9bbb6",
  "productndc": "59651-805",
  "dosage_form": "GRANULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "218948",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE/PACKET",
        "product_no": "001",
        "approval_date": "Apr 15, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE/PACKET",
        "product_no": "002",
        "approval_date": "Apr 15, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE/PACKET",
        "product_no": "003",
        "approval_date": "Apr 15, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE",
  "proprietary_name": "Esomeprazole Magnesium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA218948",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Esomeprazole Magnesium",
  "start_marketing_date": "20250415",
  "active_numerator_strength": "40"
}

Related drugs

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