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United States · US · US:0008-0923_a7e7d657-a748-4234-8dd6-c0e4d0f81a86

Protonix

Orange BookUNIISPLATC A02BC02

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

Identification

ManufacturerWyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
CountryUS (United States)
ATC codeA02BC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0008092351
    1 VIAL in 1 CARTON (0008-0923-51) / 10 mL in 1 VIAL
  • ndc11
    0008092355
    10 CARTON in 1 PACKAGE (0008-0923-55) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL
  • ndc11
    0008092360
    25 CARTON in 1 PACKAGE (0008-0923-60) / 1 VIAL in 1 CARTON / 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": "0008-0923_a7e7d657-a748-4234-8dd6-c0e4d0f81a86",
  "productndc": "0008-0923",
  "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"
}

Related drugs

Other records sharing ATC code A02BC02.

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