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United States · US · US:0113-0058_6916a481-6168-4c6f-8889-d8a207ce9d97

Good Sense Omeprazole and Sodium Bicarbonate

Orange BookUNIISPLATC A02BC

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

Identification

ManufacturerL. Perrigo Company
CountryUS (United States)
ATC codeA02BC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0113005803
    3 BOTTLE in 1 CARTON (0113-0058-03) / 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": {
    "d503b10f-85cd-4bb8-9dec-82d651d525fa": {
      "match": "brand_token",
      "title": "GOOD NEIGHBOR PHARMACY EARWAX REMOVAL (CARBAMIDE PEROXIDE) KIT [AMERISOURCE BERGEN]",
      "spl_version": "3",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0113-0058_6916a481-6168-4c6f-8889-d8a207ce9d97",
  "productndc": "0113-0058",
  "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": "Good Sense Omeprazole and Sodium Bicarbonate",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA201361",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Omeprazole, sodium bicarbonate",
  "start_marketing_date": "20170619",
  "active_numerator_strength": "20; 1100"
}

Related drugs

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