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United States · US · US:82632-100_7e277414-7482-4bfc-935b-aee179357434

Zegerid OTC

Orange BookUNIISPLATC A02BC

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

Identification

ManufacturerRiley Consumer Care LLC
CountryUS (United States)
ATC codeA02BC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8263210001
    1 BOTTLE in 1 CARTON (82632-100-01) / 14 CAPSULE in 1 BOTTLE
  • ndc11
    8263210003
    1 BOTTLE in 1 CARTON (82632-100-03) / 42 CAPSULE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
N022281
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": {
    "cd6868b9-5824-442b-8d65-4db29ecb70a4": {
      "match": "brand_token",
      "title": "ZEGERID (OMEPRAZOLE AND SODIUM BICARBONATE) POWDER, FOR SUSPENSION ZEGERID (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE [SANTARUS, INC..]",
      "spl_version": "53",
      "published_date": "2026-04-02"
    }
  },
  "productid": "82632-100_7e277414-7482-4bfc-935b-aee179357434",
  "productndc": "82632-100",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "022281",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "20MG;1.1GM",
        "product_no": "001",
        "approval_date": "Dec 1, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "OMEPRAZOLE; SODIUM BICARBONATE",
  "proprietary_name": "Zegerid OTC",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA022281",
  "marketing_category": "NDA",
  "nonproprietary_name": "Omeprazole, Sodium Bicarbonate",
  "start_marketing_date": "20240301",
  "active_numerator_strength": "20; 1100"
}

Related drugs

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