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United States · US · US:69097-914_d7eae0fc-9dfd-48d5-9491-e785fd66d5ec

omeprazole sodium bicarbonate

Orange BookUNIISPLATC A02BC

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

Identification

ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeA02BC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6909791402
    30 CAPSULE in 1 BOTTLE (69097-914-02)
  • ndc11
    6909791412
    500 CAPSULE in 1 BOTTLE (69097-914-12)

Annotations

UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
A207476
ABAB
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": "69097-914_d7eae0fc-9dfd-48d5-9491-e785fd66d5ec",
  "productndc": "69097-914",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "207476",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG;1.1GM",
        "product_no": "001",
        "approval_date": "Dec 6, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG;1.1GM",
        "product_no": "002",
        "approval_date": "Dec 6, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OMEPRAZOLE; SODIUM BICARBONATE",
  "proprietary_name": "omeprazole sodium bicarbonate",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA207476",
  "marketing_category": "ANDA",
  "nonproprietary_name": "omeprazole sodium bicarbonate",
  "start_marketing_date": "20170130",
  "active_numerator_strength": "40; 1100"
}

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