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United States · US · US:64380-182_2ac68a93-2f3b-46aa-a874-c109ad1bfefe

Omeprazole/Sodium Bicarbonate

Orange BookUNIISPLATC A02BC

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

Identification

ManufacturerStrides Pharma Science Limited
CountryUS (United States)
ATC codeA02BC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6438018202
    30 POUCH in 1 CARTON (64380-182-02) / 20 mg in 1 POUCH (64380-182-01)

Annotations

UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
A079182
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": {
    "cf6d293e-d70d-443e-8292-d693e93aab55": {
      "match": "brand_token",
      "title": "OMEPRAZOLE/SODIUM BICARBONATE (OMEPRAZOLE) POWDER, FOR SUSPENSION [STRIDES PHARMA SCIENCE LIMITED]",
      "spl_version": "5",
      "published_date": "2023-12-13"
    }
  },
  "productid": "64380-182_2ac68a93-2f3b-46aa-a874-c109ad1bfefe",
  "productndc": "64380-182",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "079182",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG/PACKET;1.68GM/PACKET",
        "product_no": "001",
        "approval_date": "Apr 19, 2013"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG/PACKET;1.68GM/PACKET",
        "product_no": "002",
        "approval_date": "Apr 19, 2013"
      }
    ],
    "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/1700mg; mg/1700mg",
  "application_number": "ANDA079182",
  "marketing_category": "ANDA",
  "nonproprietary_name": "omeprazole",
  "start_marketing_date": "20221001",
  "active_numerator_strength": "20; 1680"
}

Related drugs

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