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United States · US · US:37808-115_3b06de5f-2bf2-af31-3079-9d66dcd5cd3b

Esomeprazole Magnesium

Orange BookSPLATC A02BC05

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

Identification

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

Packs · 3

  • ndc11
    3780811514
    1 BOTTLE in 1 CARTON (37808-115-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • ndc11
    3780811528
    2 BOTTLE in 1 CARTON (37808-115-28) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • ndc11
    3780811542
    3 BOTTLE in 1 CARTON (37808-115-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Annotations

Orange Book
A207673
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": "37808-115_3b06de5f-2bf2-af31-3079-9d66dcd5cd3b",
  "productndc": "37808-115",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "207673",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "May 15, 2018"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ESOMEPRAZOLE MAGNESIUM",
  "proprietary_name": "Esomeprazole Magnesium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207673",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Esomeprazole Magnesium",
  "start_marketing_date": "20190324",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code A02BC05.

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