Esomeprazole magnesium

Orange BookSPLATC A02BC05

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

Identification

ManufacturerBryant Ranch Prepack

CountryUS (United States)

ATC codeA02BC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
7133596781
30 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-1)
ndc11
7133596782
10 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-2)
ndc11
7133596783
60 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-3)
ndc11
7133596784
90 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-4)
ndc11
7133596785
42 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-5)
ndc11
7133596786
120 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-6)
ndc11
7133596787
180 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-7)
ndc11
7133596788
20 CAPSULE, COATED PELLETS in 1 BOTTLE (71335-9678-8)

Annotations

Orange Book

A210559

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": "71335-9678_e5116491-c738-4e54-9383-d8a4c7494fa0",
  "productndc": "71335-9678",
  "dosage_form": "CAPSULE, COATED PELLETS",
  "orange_book": {
    "appl_no": "210559",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Feb 26, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Feb 26, 2021"
      }
    ],
    "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": "ANDA210559",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Esomeprazole magnesium delayed release capsules",
  "start_marketing_date": "20210227",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code A02BC05.

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