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United States · US · US:82009-039_2f333840-e837-3207-e063-6294a90aea03

Lansoprazole

Orange BookUNIISPLATC A02BC03

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

Identification

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

Packs · 1

  • ndc11
    8200903905
    500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (82009-039-05)

Annotations

UNII (FDA Substance ID)
0K5C5T2QPG
LANSOPRAZOLE
RxCUI 17128
Orange Book
A203083
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": "82009-039_2f333840-e837-3207-e063-6294a90aea03",
  "productndc": "82009-039",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "203083",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "May 18, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "May 18, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LANSOPRAZOLE",
  "proprietary_name": "Lansoprazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA203083",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lansoprazole",
  "start_marketing_date": "20221014",
  "active_numerator_strength": "30"
}

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