PANTOPRAZOLE SODIUM

Orange BookUNIISPLATC A02BC02

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

Identification

ManufacturerBaxter Healthcare Corporation

CountryUS (United States)

ATC codeA02BC02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0338964412
12 BAG in 1 CARTON (0338-9644-12) / 100 mL in 1 BAG (0338-9644-01)

Annotations

UNII (FDA Substance ID)

6871619Q5X

PANTOPRAZOLE SODIUM

RxCUI 236632

Orange Book

N217512

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": "INTRAVENOUS",
  "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": "0338-9644_290e26a2-61f1-4840-9819-205212c7d365",
  "productndc": "0338-9644",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "217512",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Feb 14, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML)",
        "product_no": "002",
        "approval_date": "Feb 14, 2024"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML)",
        "product_no": "003",
        "approval_date": "Feb 14, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PANTOPRAZOLE SODIUM",
  "proprietary_name": "PANTOPRAZOLE SODIUM",
  "active_ingred_unit": "mg/100mL",
  "application_number": "NDA217512",
  "marketing_category": "NDA",
  "nonproprietary_name": "Pantoprazole Sodium in 0.9% Sodium Chloride",
  "start_marketing_date": "20240214",
  "active_numerator_strength": "40"
}

Related drugs

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