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United States · US · US:37808-719_e03b4775-6fd8-4d45-83e8-bc405104c539

Esomeprazole Magnesium

Orange BookUNIISPLATC A02BC05

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

Identification

ManufacturerH E B
CountryUS (United States)
ATC codeA02BC05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    3780871901
    1 BOTTLE in 1 CARTON (37808-719-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • ndc11
    3780871903
    3 BOTTLE in 1 CARTON (37808-719-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
N3PA6559FT
ESOMEPRAZOLE
RxCUI 283742
Orange Book
A207193
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "N3PA6559FT",
    "rxcui": "283742",
    "inchikey": "SUBDBMMJDZJVOS-DEOSSOPVSA-N",
    "display_name": "ESOMEPRAZOLE",
    "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": "37808-719_e03b4775-6fd8-4d45-83e8-bc405104c539",
  "productndc": "37808-719",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "207193",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Aug 18, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ESOMEPRAZOLE",
  "proprietary_name": "Esomeprazole Magnesium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207193",
  "marketing_category": "ANDA",
  "nonproprietary_name": "esomeprazole",
  "start_marketing_date": "20200806",
  "active_numerator_strength": "20"
}

Related drugs

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