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United States · US · US:85509-1332_43fc6335-4b31-60bc-e063-6294a90a7362

Pantoprazole

Orange BookUNIISPLATC A02BC02

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

Identification

ManufacturerPHOENIX RX LLC
CountryUS (United States)
ATC codeA02BC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8550913323
    30 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1332-3)
  • ndc11
    8550913326
    60 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1332-6)
  • ndc11
    8550913329
    90 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1332-9)

Annotations

UNII (FDA Substance ID)
6871619Q5X
PANTOPRAZOLE SODIUM
RxCUI 236632
Orange Book
A077619
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6871619Q5X",
    "rxcui": "236632",
    "inchikey": "VNKNFEINTHUQGZ-UHFFFAOYSA-N",
    "display_name": "PANTOPRAZOLE SODIUM",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "52bbab54-9f11-77bc-e063-6394a90ab449": {
      "match": "brand_token",
      "title": "PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [COUPLER LLC]",
      "spl_version": "1",
      "published_date": "2026-05-28"
    }
  },
  "productid": "85509-1332_43fc6335-4b31-60bc-e063-6294a90a7362",
  "productndc": "85509-1332",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "077619",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Jan 19, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Jan 19, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PANTOPRAZOLE SODIUM",
  "proprietary_name": "Pantoprazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077619",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pantoprazole",
  "start_marketing_date": "20110119",
  "active_numerator_strength": "20"
}

Related drugs

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