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United States · US · US:55154-4236_435bdafe-e862-45bf-8432-bcb56944009f

Protonix

Orange BookUNIISPLATC A02BC02

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

Identification

ManufacturerCardinal Health 107, LLC
CountryUS (United States)
ATC codeA02BC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5515442365
    5 VIAL in 1 CARTON (55154-4236-5) / 10 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
6871619Q5X
PANTOPRAZOLE SODIUM
RxCUI 236632
Orange Book
N020988
AP
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": {
    "08098cb2-c048-4640-f387-6beec4a38936": {
      "match": "brand_token",
      "title": "PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]",
      "spl_version": "48",
      "published_date": "2026-05-20"
    }
  },
  "productid": "55154-4236_435bdafe-e862-45bf-8432-bcb56944009f",
  "productndc": "55154-4236",
  "dosage_form": "INJECTION, POWDER, FOR SOLUTION",
  "orange_book": {
    "appl_no": "020988",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 40MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "Mar 22, 2001"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PANTOPRAZOLE SODIUM",
  "proprietary_name": "Protonix",
  "active_ingred_unit": "mg/10mL",
  "application_number": "NDA020988",
  "marketing_category": "NDA",
  "nonproprietary_name": "PANTOPRAZOLE SODIUM",
  "start_marketing_date": "20010501",
  "active_numerator_strength": "40"
}

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