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United States · US · US:80425-0278_2a9bf621-afb8-7627-e063-6294a90a77a9

Pantoprazole Sodium

Orange BookUNIISPLATC A02BC02

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

Identification

ManufacturerAdvanced Rx Pharmacy of Tennessee, LLC
CountryUS (United States)
ATC codeA02BC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8042502781
    30 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0278-1)
  • ndc11
    8042502782
    60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0278-2)
  • ndc11
    8042502783
    90 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0278-3)

Annotations

UNII (FDA Substance ID)
6871619Q5X
PANTOPRAZOLE SODIUM
RxCUI 236632
Orange Book
A202882
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": "80425-0278_2a9bf621-afb8-7627-e063-6294a90a77a9",
  "productndc": "80425-0278",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "202882",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 20MG BASE",
        "product_no": "001",
        "approval_date": "Sep 10, 2014"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "002",
        "approval_date": "Sep 10, 2014"
      }
    ],
    "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": "ANDA202882",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pantoprazole Sodium",
  "start_marketing_date": "20230228",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code A02BC02.

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