Pantoprazole Sodium

Orange BookUNIISPLATC A02BC02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAvPAK

CountryUS (United States)

ATC codeA02BC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5026858515
50 BLISTER PACK in 1 BOX (50268-585-15) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (50268-585-11)

Annotations

UNII (FDA Substance ID)

6871619Q5X

PANTOPRAZOLE SODIUM

RxCUI 236632

Orange Book

A078281

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": "50268-585_4510e1ae-df21-156c-e063-6394a90a09da",
  "productndc": "50268-585",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "078281",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Jan 20, 2011"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Jan 20, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PANTOPRAZOLE SODIUM",
  "proprietary_name": "Pantoprazole Sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078281",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pantoprazole Sodium",
  "start_marketing_date": "20210128",
  "active_numerator_strength": "20"
}

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