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United States · US · US:75907-138_3ccc6e19-1da7-caa1-2b51-6946e92a1a79

Omeprazole and Sodium Bicarbonate

Orange BookUNIISPLATC A02BC

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

Identification

ManufacturerDr. Reddy's Laboratories Inc.,
CountryUS (United States)
ATC codeA02BC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7590713842
    42 PACKET in 1 CARTON (75907-138-42) / 1 POWDER, FOR SUSPENSION in 1 PACKET

Annotations

UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
A217784
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": "75907-138_3ccc6e19-1da7-caa1-2b51-6946e92a1a79",
  "productndc": "75907-138",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "217784",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG/PACKET;1.68GM/PACKET",
        "product_no": "001",
        "approval_date": "May 9, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "OMEPRAZOLE; SODIUM BICARBONATE",
  "proprietary_name": "Omeprazole and Sodium Bicarbonate",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA217784",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Omeprazole and Sodium Bicarbonate",
  "start_marketing_date": "20240715",
  "active_numerator_strength": "20; 1680"
}

Related drugs

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