Esomeprazole Magnesium

Orange BookUNIISPLATC A02BC05

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

Identification

ManufacturerAurobindo Pharma Limited

CountryUS (United States)

ATC codeA02BC05

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 5

ndc11
6586278401
100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-784-01)
ndc11
6586278430
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-784-30)
ndc11
6586278478
10 BLISTER PACK in 1 CARTON (65862-784-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (65862-784-10)
ndc11
6586278490
90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-784-90)
ndc11
6586278499
1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65862-784-99)

Annotations

UNII (FDA Substance ID)

36H71644EQ

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

RxCUI 1601995

Orange Book

A205606

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "36H71644EQ",
    "rxcui": "1601995",
    "inchikey": "DBOUSUONOXEWHU-VCKZSRROSA-N",
    "display_name": "ESOMEPRAZOLE MAGNESIUM DIHYDRATE",
    "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": "65862-784_7da643d0-40fb-4ead-8d34-a95c2a8334f7",
  "productndc": "65862-784",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "205606",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Apr 21, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Apr 21, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESOMEPRAZOLE MAGNESIUM DIHYDRATE",
  "proprietary_name": "Esomeprazole Magnesium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA205606",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Esomeprazole Magnesium",
  "start_marketing_date": "20160421",
  "active_numerator_strength": "40"
}

Related drugs

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