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United States · US · US:72559-011_1b1a0d42-2f12-fb82-e063-6394a90af12f

Esomeprazole Magnesium

Orange BookSPLATC A02BC05

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

Identification

ManufacturerLITTLE PHARMA, INC.
CountryUS (United States)
ATC codeA02BC05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7255901106
    3 BOTTLE in 1 CARTON (72559-011-06) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • ndc11
    7255901107
    14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72559-011-07)
  • ndc11
    7255901136
    4 CARTON in 1 PACKAGE, COMBINATION (72559-011-36) / 3 BOTTLE in 1 CARTON / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Annotations

Orange Book
A212866
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": "72559-011_1b1a0d42-2f12-fb82-e063-6394a90af12f",
  "productndc": "72559-011",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "212866",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "May 4, 2020"
      }
    ],
    "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": "ANDA212866",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Esomeprazole Magnesium",
  "start_marketing_date": "20210323",
  "active_numerator_strength": "20"
}

Related drugs

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