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United States · US · US:70095-024_b423abbc-01e1-4d07-9c89-a7398c898d2f

Pantoprazole sodium

Orange BookUNIISPLATC A02BC02

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

Identification

ManufacturerSun Pharmaceutical Industries Limited
CountryUS (United States)
ATC codeA02BC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7009502402
    10 CARTON in 1 PACKAGE (70095-024-02) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL (70095-024-01)
  • ndc11
    7009502403
    25 CARTON in 1 PACKAGE (70095-024-03) / 1 VIAL in 1 CARTON / 10 mL in 1 VIAL (70095-024-01)

Annotations

UNII (FDA Substance ID)
6871619Q5X
PANTOPRAZOLE SODIUM
RxCUI 236632
Orange Book
A204400
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": {
    "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": "70095-024_b423abbc-01e1-4d07-9c89-a7398c898d2f",
  "productndc": "70095-024",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "204400",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 40MG BASE/VIAL",
        "product_no": "001",
        "approval_date": "May 18, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PANTOPRAZOLE SODIUM",
  "proprietary_name": "Pantoprazole sodium",
  "active_ingred_unit": "mg/10mL",
  "application_number": "ANDA204400",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pantoprazole sodium",
  "start_marketing_date": "20230403",
  "active_numerator_strength": "40"
}

Related drugs

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