esomeprazole magnesium

Orange BookUNIISPLATC A02BC05

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.

CountryUS (United States)

ATC codeA02BC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6878885241
100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-1)
ndc11
6878885242
20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-2)
ndc11
6878885243
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-3)
ndc11
6878885246
60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-6)
ndc11
6878885249
90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-9)

Annotations

UNII (FDA Substance ID)

R6DXU4WAY9

ESOMEPRAZOLE MAGNESIUM TRIHYDRATE

RxCUI 283562

Orange Book

A213486

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "R6DXU4WAY9",
    "rxcui": "283562",
    "inchikey": "VEVZQDGATGBLIC-OXLUMUBXSA-N",
    "display_name": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "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": "68788-8524_efc27899-0425-4367-80ea-3045c6eb59f5",
  "productndc": "68788-8524",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "213486",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Mar 19, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Mar 19, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE",
  "proprietary_name": "esomeprazole magnesium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213486",
  "marketing_category": "ANDA",
  "nonproprietary_name": "esomeprazole magnesium",
  "start_marketing_date": "20230914",
  "active_numerator_strength": "40"
}

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