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United States · US · US:70849-200_3d19523d-7cb5-2f2f-e054-00144ff88e88

ESOMEPRAZOLE STRONTIUM

Orange BookUNIISPLATC A02BC

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

Identification

ManufacturerR2 Pharma, LLC
CountryUS (United States)
ATC codeA02BC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7084920030
    30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70849-200-30)

Annotations

UNII (FDA Substance ID)
C5N25H3803
ESOMEPRAZOLE STRONTIUM
RxCUI 1435522
Orange Book
N202342
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "C5N25H3803",
    "rxcui": "1435522",
    "inchikey": "NCGHIAKEJNQSMS-QLGOZJDFSA-N",
    "display_name": "ESOMEPRAZOLE STRONTIUM",
    "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": "70849-200_3d19523d-7cb5-2f2f-e054-00144ff88e88",
  "productndc": "70849-200",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "202342",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "24.65MG",
        "product_no": "001",
        "approval_date": "Aug 6, 2013"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "49.3MG",
        "product_no": "002",
        "approval_date": "Aug 6, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESOMEPRAZOLE STRONTIUM",
  "proprietary_name": "ESOMEPRAZOLE STRONTIUM",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA202342",
  "marketing_category": "NDA",
  "nonproprietary_name": "esomeprazole strontium",
  "start_marketing_date": "20160915",
  "active_numerator_strength": "20"
}

Related drugs

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