Esomeprazole magnesium

Orange BookSPLATC A02BC05

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

Identification

ManufacturerAscend Laboratories, LLC

CountryUS (United States)

ATC codeA02BC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6787757105
500 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-05)
ndc11
6787757110
1000 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-10)
ndc11
6787757130
30 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-30)
ndc11
6787757138
10 BLISTER PACK in 1 CARTON (67877-571-38) / 10 CAPSULE, COATED PELLETS in 1 BLISTER PACK
ndc11
6787757190
90 CAPSULE, COATED PELLETS in 1 BOTTLE (67877-571-90)

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": "67877-571_27b22eed-c148-41cd-bdd7-434610f98b70",
  "productndc": "67877-571",
  "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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