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United States · US · US:68682-104_342c0d17-867e-d8da-e063-6394a90a3151

Omeprazole and Sodium Bicarbonate

Orange BookUNIISPLATC A02BC

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

Identification

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

Packs · 1

  • ndc11
    6868210430
    30 CAPSULE in 1 BOTTLE (68682-104-30)

Annotations

UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
N021849
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "KG60484QX9",
    "rxcui": "7646",
    "inchikey": "SUBDBMMJDZJVOS-UHFFFAOYSA-N",
    "display_name": "OMEPRAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "b3ec4a44-5643-4438-b41b-e04946436719": {
      "match": "brand_token",
      "title": "OMEPRAZOLE CAPSULE, DELAYED RELEASE [SAFEWAY]",
      "spl_version": "3",
      "published_date": "2026-05-29"
    }
  },
  "productid": "68682-104_342c0d17-867e-d8da-e063-6394a90a3151",
  "productndc": "68682-104",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "021849",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "20MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "Feb 27, 2006"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "40MG;1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "002",
        "approval_date": "Feb 27, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OMEPRAZOLE; SODIUM BICARBONATE",
  "proprietary_name": "Omeprazole and Sodium Bicarbonate",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA021849",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "omeprazole, sodium bicarbonate",
  "start_marketing_date": "20060227",
  "active_numerator_strength": "40; 1100"
}

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