Back to search
🇺🇸

United States · US · US:85509-1032_3b2cf695-7671-4ad0-e063-6294a90aeb46

Omeprazole and Sodium Bicarbonate

Orange BookUNIISPLATC A02BC

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

Identification

ManufacturerPHOENIX RX LLC
CountryUS (United States)
ATC codeA02BC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8550910321
    15 CAPSULE in 1 BOTTLE (85509-1032-1)
  • ndc11
    8550910323
    30 CAPSULE in 1 BOTTLE (85509-1032-3)
  • ndc11
    8550910326
    60 CAPSULE in 1 BOTTLE (85509-1032-6)

Annotations

UNII (FDA Substance ID)
KG60484QX9
OMEPRAZOLE
RxCUI 7646
Orange Book
A204228
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": "85509-1032_3b2cf695-7671-4ad0-e063-6294a90aeb46",
  "productndc": "85509-1032",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "204228",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG;1.1GM",
        "product_no": "001",
        "approval_date": "Jul 15, 2016"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG;1.1GM",
        "product_no": "002",
        "approval_date": "Jul 15, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "OMEPRAZOLE; SODIUM BICARBONATE",
  "proprietary_name": "Omeprazole and Sodium Bicarbonate",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA204228",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Omeprazole and Sodium Bicarbonate",
  "start_marketing_date": "20250730",
  "active_numerator_strength": "40; 1100"
}

Related drugs

Other records sharing ATC code A02BC.

Access this data programmatically

Query Omeprazole and Sodium Bicarbonate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.