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United States · US · US:69097-531_176f3856-e33d-4fb2-9fe9-72d96c5eabe8

PANTOPRAZOLE SODIUM DELAYED-RELEASE

Orange BookUNIISPLATC A02BC02

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

Identification

ManufacturerCipla USA Inc.
CountryUS (United States)
ATC codeA02BC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6909753153
    30 PACKET in 1 CARTON (69097-531-53) / 1 SUSPENSION in 1 PACKET (69097-531-31)

Annotations

UNII (FDA Substance ID)
6871619Q5X
PANTOPRAZOLE SODIUM
RxCUI 236632
Orange Book
A217458
AB
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": "69097-531_176f3856-e33d-4fb2-9fe9-72d96c5eabe8",
  "productndc": "69097-531",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "217458",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "001",
        "approval_date": "Mar 31, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PANTOPRAZOLE SODIUM",
  "proprietary_name": "PANTOPRAZOLE SODIUM DELAYED-RELEASE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217458",
  "marketing_category": "ANDA",
  "nonproprietary_name": "pantoprazole sodium granules",
  "start_marketing_date": "20250403",
  "active_numerator_strength": "40"
}

Related drugs

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