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United States · US · US:70756-019_2c507c43-c033-4b6e-b954-f0f2fb617289

Pantoprazole sodium delayed-release

Orange BookUNIISPLATC A02BC02

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

Identification

ManufacturerLifestar Pharma LLC
CountryUS (United States)
ATC codeA02BC02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7075601912
    1000 TABLET in 1 BOTTLE (70756-019-12)
  • ndc11
    7075601990
    90 TABLET in 1 BOTTLE (70756-019-90)

Annotations

UNII (FDA Substance ID)
6871619Q5X
PANTOPRAZOLE SODIUM
RxCUI 236632
Orange Book
A215880
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": "70756-019_2c507c43-c033-4b6e-b954-f0f2fb617289",
  "productndc": "70756-019",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "215880",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 40MG BASE",
        "product_no": "001",
        "approval_date": "Jul 26, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 20MG BASE",
        "product_no": "002",
        "approval_date": "Apr 25, 2024"
      }
    ],
    "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": "ANDA215880",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Pantoprazole sodium delayed-release",
  "start_marketing_date": "20220727",
  "active_numerator_strength": "40"
}

Related drugs

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