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United States · US · US:82461-713_1d65f51d-0c4e-4344-8669-691f5223e4c5

Lansoprazole

Orange BookUNIISPLATC A02BC03

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

Identification

ManufacturerMedcore LLC
CountryUS (United States)
ATC codeA02BC03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8246171330
    30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82461-713-30)

Annotations

UNII (FDA Substance ID)
0K5C5T2QPG
LANSOPRAZOLE
RxCUI 17128
Orange Book
A207394
ABAB
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": "82461-713_1d65f51d-0c4e-4344-8669-691f5223e4c5",
  "productndc": "82461-713",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "207394",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Jan 18, 2019"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Jan 18, 2019"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LANSOPRAZOLE",
  "proprietary_name": "Lansoprazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA207394",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lansoprazole",
  "start_marketing_date": "20260111",
  "active_numerator_strength": "30"
}

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