PANTOPRAZOLE SODIUM

Orange BookUNIISPLATC A02BC02

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

Identification

ManufacturerQuallent Pharmaceuticals Health LLC

CountryUS (United States)

ATC codeA02BC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
8200901110
1000 TABLET, DELAYED RELEASE in 1 BOTTLE (82009-011-10)
ndc11
8200901190
90 TABLET, DELAYED RELEASE in 1 BOTTLE (82009-011-90)

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": "82009-011_48430767-cec0-15e0-e063-6394a90ac032",
  "productndc": "82009-011",
  "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",
  "start_marketing_date": "20220606",
  "active_numerator_strength": "40"
}

Related drugs

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