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United States · US · US:82632-699_a67c46ad-327c-4561-92ce-27f6ce3e76c6

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
    8263269901
    1 BOTTLE in 1 CARTON (82632-699-01) / 14 CAPSULE, GELATIN COATED in 1 BOTTLE
  • ndc11
    8263269903
    3 BOTTLE in 1 CARTON (82632-699-03) / 14 CAPSULE, GELATIN COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
A201361
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": "82632-699_a67c46ad-327c-4561-92ce-27f6ce3e76c6",
  "productndc": "82632-699",
  "dosage_form": "CAPSULE, GELATIN COATED",
  "orange_book": {
    "appl_no": "201361",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG;1.1GM",
        "product_no": "001",
        "approval_date": "Jul 15, 2016"
      }
    ],
    "appl_type": "A"
  },
  "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": "ANDA201361",
  "marketing_category": "ANDA",
  "nonproprietary_name": "omepraole, sodium bicarbonate",
  "start_marketing_date": "20240110",
  "active_numerator_strength": "20; 1100"
}

Related drugs

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