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United States · US · US:0186-4040_26f66e74-b652-4b1d-bfff-62a3cc87d590

NEXIUM

Orange BookUNIISPLATC A02BC05

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAstraZeneca Pharmaceuticals LP
CountryUS (United States)
ATC codeA02BC05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0186404001
    30 GRANULE, DELAYED RELEASE in 1 CARTON (0186-4040-01)

Annotations

UNII (FDA Substance ID)
R6DXU4WAY9
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
RxCUI 283562
Orange Book
N021957
ABABABAB
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": {
    "f4853677-1622-4037-688b-fdf533a11d96": {
      "match": "brand_token",
      "title": "NEXIUM (ESOMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE NEXIUM (ESOMEPRAZOLE MAGNESIUM) GRANULE, DELAYED RELEASE [ASTRAZENECA PHARMACEUTICALS LP]",
      "spl_version": "74",
      "published_date": "2026-04-13"
    }
  },
  "productid": "0186-4040_26f66e74-b652-4b1d-bfff-62a3cc87d590",
  "productndc": "0186-4040",
  "dosage_form": "GRANULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "021957",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 20MG BASE/PACKET",
        "product_no": "001",
        "approval_date": "Oct 20, 2006"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 40MG BASE/PACKET",
        "product_no": "002",
        "approval_date": "Oct 20, 2006"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 2.5MG BASE/PACKET",
        "product_no": "003",
        "approval_date": "Dec 15, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "EQ 5MG BASE/PACKET",
        "product_no": "004",
        "approval_date": "Dec 15, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE",
  "proprietary_name": "NEXIUM",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021957",
  "marketing_category": "NDA",
  "nonproprietary_name": "Esomeprazole magnesium",
  "start_marketing_date": "20070319",
  "active_numerator_strength": "40"
}

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