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United States · US · US:68788-8906_470496f5-a71d-40b2-bf11-3a8d3d790962

Naproxen and esomeprazole magnesium

Orange BookUNIISPLATC A02BC

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

Identification

ManufacturerPreferred Pharmaceuticals Inc
CountryUS (United States)
ATC codeA02BC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6878889063
    30 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8906-3)
  • ndc11
    6878889066
    60 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8906-6)

Annotations

UNII (FDA Substance ID)
R6DXU4WAY9
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
RxCUI 283562
Orange Book
A217738
ABAB
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": {
    "c5146d73-2f34-4dfe-ac29-97071279dc4d": {
      "match": "brand_token",
      "title": "NAPROXEN SODIUM TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]",
      "spl_version": "10",
      "published_date": "2026-05-28"
    }
  },
  "productid": "68788-8906_470496f5-a71d-40b2-bf11-3a8d3d790962",
  "productndc": "68788-8906",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "217738",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE;375MG",
        "product_no": "001",
        "approval_date": "Oct 11, 2023"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE;500MG",
        "product_no": "002",
        "approval_date": "Oct 11, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ESOMEPRAZOLE MAGNESIUM TRIHYDRATE; NAPROXEN",
  "proprietary_name": "Naproxen and esomeprazole magnesium",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA217738",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen and esomeprazole magnesium",
  "start_marketing_date": "20250731",
  "active_numerator_strength": "20; 375"
}

Related drugs

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