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United States · US · US:68788-4043_6368a3be-4b79-466b-8ec4-11fc3ac623cc

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
    6878840433
    30 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-4043-3)
  • ndc11
    6878840436
    60 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-4043-6)

Annotations

UNII (FDA Substance ID)
R6DXU4WAY9
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
RxCUI 283562
Orange Book
A204206
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": "68788-4043_6368a3be-4b79-466b-8ec4-11fc3ac623cc",
  "productndc": "68788-4043",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "204206",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE;375MG",
        "product_no": "001",
        "approval_date": "Feb 18, 2020"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE;500MG",
        "product_no": "002",
        "approval_date": "Feb 18, 2020"
      }
    ],
    "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": "ANDA204206",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Naproxen and esomeprazole magnesium",
  "start_marketing_date": "20251017",
  "active_numerator_strength": "20; 500"
}

Related drugs

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