Pantoprazole Sodium

Orange BookUNIISPLATC A02BC02

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

Identification

ManufacturerMajor Pharmaceuticals

CountryUS (United States)

ATC codeA02BC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
0904647406
50 BLISTER PACK in 1 CARTON (0904-6474-06) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK
ndc11
0904647461
100 BLISTER PACK in 1 CARTON (0904-6474-61) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

6871619Q5X

PANTOPRAZOLE SODIUM

RxCUI 236632

Orange Book

A090074

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": "0904-6474_349f9634-a35a-487f-acec-9148dba002cf",
  "productndc": "0904-6474",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "090074",
    "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 Sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090074",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pantoprazole Sodium",
  "start_marketing_date": "20150601",
  "active_numerator_strength": "40"
}

Related drugs

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