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United States · US · US:45802-878_5032a392-a20a-4246-b2cb-54d7e3a441f8

lansoprazole

Orange BookUNIISPLATC A02BC03

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

Identification

ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeA02BC03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4580287801
    1 BOTTLE in 1 CARTON (45802-878-01) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • ndc11
    4580287802
    2 BOTTLE in 1 CARTON (45802-878-02) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • ndc11
    4580287803
    3 BOTTLE in 1 CARTON (45802-878-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
0K5C5T2QPG
LANSOPRAZOLE
RxCUI 17128
Orange Book
A202319
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "0K5C5T2QPG",
    "rxcui": "17128",
    "inchikey": "MJIHNNLFOKEZEW-UHFFFAOYSA-N",
    "display_name": "LANSOPRAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c9a43df0-efab-4486-860f-92afdb258c8b": {
      "match": "brand_token",
      "title": "LANSOPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [CARDINAL HEALTH 107, LLC]",
      "spl_version": "5",
      "published_date": "2026-06-01"
    }
  },
  "productid": "45802-878_5032a392-a20a-4246-b2cb-54d7e3a441f8",
  "productndc": "45802-878",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "202319",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "May 18, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LANSOPRAZOLE",
  "proprietary_name": "lansoprazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202319",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lansoprazole",
  "start_marketing_date": "20210729",
  "active_numerator_strength": "15"
}

Related drugs

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