Esomeprazole Magnesium

Orange BookSPLATC A02BC05

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerTorrent Pharmaceuticals Limited

CountryUS (United States)

ATC codeA02BC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1366855094
30 GRANULE, DELAYED RELEASE in 1 CARTON (13668-550-94)

Annotations

Orange Book

A212651

ABABABAB

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": "13668-550_48a063bb-b163-40f3-ad34-728d86410249",
  "productndc": "13668-550",
  "dosage_form": "GRANULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "212651",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE/PACKET",
        "product_no": "001",
        "approval_date": "Mar 5, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 5MG BASE/PACKET",
        "product_no": "002",
        "approval_date": "Mar 5, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE/PACKET",
        "product_no": "003",
        "approval_date": "Mar 5, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE/PACKET",
        "product_no": "004",
        "approval_date": "Mar 5, 2025"
      }
    ],
    "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": "ANDA212651",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Esomeprazole Magnesium",
  "start_marketing_date": "20250305",
  "active_numerator_strength": "40"
}

Related drugs

Other records sharing ATC code A02BC05.

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