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United States · US · US:71335-2449_f1d20353-c0e3-4ae0-9f8f-01cc6e9fa5a7

Esomeprazole magnesium

Orange BookSPLATC A02BC05

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

Identification

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

Packs · 7

  • ndc11
    7133524491
    90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2449-1)
  • ndc11
    7133524492
    30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2449-2)
  • ndc11
    7133524493
    60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2449-3)
  • ndc11
    7133524494
    10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2449-4)
  • ndc11
    7133524495
    20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2449-5)
  • ndc11
    7133524496
    120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2449-6)
  • ndc11
    7133524497
    180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2449-7)

Annotations

Orange Book
A217427
ABAB
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": "71335-2449_f1d20353-c0e3-4ae0-9f8f-01cc6e9fa5a7",
  "productndc": "71335-2449",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "217427",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Oct 18, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Oct 18, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESOMEPRAZOLE MAGNESIUM",
  "proprietary_name": "Esomeprazole magnesium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217427",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Esomeprazole magnesium",
  "start_marketing_date": "20231018",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code A02BC05.

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