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United States · US · US:41520-727_96c2b7f1-ae2c-4b41-b58a-183b654a70ff

careone esomeprazole magnesium

Orange BookUNIISPLATC A02BC05

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

Identification

ManufacturerAmerican Sales Company
CountryUS (United States)
ATC codeA02BC05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4152072701
    1 BOTTLE in 1 CARTON (41520-727-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • ndc11
    4152072703
    3 BOTTLE in 1 CARTON (41520-727-03) / 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": {
    "206f5483-7de1-4bc3-af27-190e211bcb95": {
      "match": "brand_token",
      "title": "CAREONE ACID RELIEF (FAMOTIDINE) TABLET, FILM COATED [AMERICAN SALES COMPANY]",
      "spl_version": "9",
      "published_date": "2026-05-25"
    }
  },
  "productid": "41520-727_96c2b7f1-ae2c-4b41-b58a-183b654a70ff",
  "productndc": "41520-727",
  "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": "careone esomeprazole magnesium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207193",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Esomeprazole",
  "start_marketing_date": "20170926",
  "active_numerator_strength": "20"
}

Related drugs

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