esomeprazole magnesium

Orange BookUNIISPLATC 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 · 7

ndc11
7133513351
90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1335-1)
ndc11
7133513352
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1335-2)
ndc11
7133513353
60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1335-3)
ndc11
7133513354
10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1335-4)
ndc11
7133513355
20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1335-5)
ndc11
7133513356
120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1335-6)
ndc11
7133513357
180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1335-7)

Annotations

UNII (FDA Substance ID)

36H71644EQ

ESOMEPRAZOLE MAGNESIUM DIHYDRATE

RxCUI 1601995

Orange Book

A206296

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": "71335-1335_601fff53-da65-4454-8727-9f31affd84a4",
  "productndc": "71335-1335",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "206296",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "May 22, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "May 22, 2019"
      }
    ],
    "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": "ANDA206296",
  "marketing_category": "ANDA",
  "nonproprietary_name": "esomeprazole magnesium",
  "start_marketing_date": "20190530",
  "active_numerator_strength": "40"
}

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