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United States · US · US:25000-096_f2f3282e-c6de-42ea-9a6f-d6b573256968

Esomeprazole Magnesium Delayed Release 20 mg mini

Orange BookSPLATC A02BC05

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

Identification

ManufacturerMARKSANS PHARMA LIMITED
CountryUS (United States)
ATC codeA02BC05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2500009676
    1 BOTTLE in 1 CARTON (25000-096-76) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Annotations

Orange Book
A217264
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "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": "25000-096_f2f3282e-c6de-42ea-9a6f-d6b573256968",
  "productndc": "25000-096",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "217264",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Sep 29, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ESOMEPRAZOLE MAGNESIUM",
  "proprietary_name": "Esomeprazole Magnesium Delayed Release 20 mg mini",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217264",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Esomeprazole Magnesium Delayed Release 20 mg mini",
  "start_marketing_date": "20260601",
  "active_numerator_strength": "20"
}

Related drugs

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