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United States · US · US:69097-508_75c5150c-7eab-4f85-9c34-80c0ecb4a07b

Esomeprazole magnesium

Orange BookUNIISPLATC A02BC05

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

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
    6909750831
    30 FOR SUSPENSION in 1 CARTON (69097-508-31)

Annotations

UNII (FDA Substance ID)
36H71644EQ
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
RxCUI 1601995
Orange Book
A217714
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": "69097-508_75c5150c-7eab-4f85-9c34-80c0ecb4a07b",
  "productndc": "69097-508",
  "dosage_form": "FOR SUSPENSION",
  "orange_book": {
    "appl_no": "217714",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE/PACKET",
        "product_no": "001",
        "approval_date": "Jan 7, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE/PACKET",
        "product_no": "002",
        "approval_date": "Jan 7, 2025"
      }
    ],
    "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": "ANDA217714",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Esomeprazole magnesium",
  "start_marketing_date": "20250107",
  "active_numerator_strength": "5"
}

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