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United States · US · US:69729-791_4dc7f12f-7e83-aca2-e063-6294a90ac1dc

RIOPAN

Orange BookSPLATC A02BC05

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

Identification

ManufacturerOPMX LLC
CountryUS (United States)
ATC codeA02BC05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6972979114
    1 BOTTLE in 1 CARTON (69729-791-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Annotations

Orange Book
A212507
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": "ORAL",
  "spl_meta": {
    "4c37280d-25b6-ad2f-e063-6394a90a0b9d": {
      "match": "brand_token",
      "title": "RIOPAN (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [OPMX LLC]",
      "spl_version": "2",
      "published_date": "2026-03-26"
    }
  },
  "productid": "69729-791_4dc7f12f-7e83-aca2-e063-6294a90ac1dc",
  "productndc": "69729-791",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "212507",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Jun 2, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ESOMEPRAZOLE MAGNESIUM",
  "proprietary_name": "RIOPAN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212507",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Esomeprazole",
  "start_marketing_date": "20260304",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code A02BC05.

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