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United States · US · US:16714-186_1e12b24b-c259-7423-cf4a-494d2fbe098b

Lansoprazole

Orange BookUNIISPLATC A02BC03

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

Identification

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

Packs · 1

  • ndc11
    1671418602
    100 BLISTER PACK in 1 CARTON (16714-186-02) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (16714-186-01)

Annotations

UNII (FDA Substance ID)
0K5C5T2QPG
LANSOPRAZOLE
RxCUI 17128
Orange Book
A210465
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": "16714-186_1e12b24b-c259-7423-cf4a-494d2fbe098b",
  "productndc": "16714-186",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "210465",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Feb 1, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Feb 1, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LANSOPRAZOLE",
  "proprietary_name": "Lansoprazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA210465",
  "marketing_category": "ANDA",
  "nonproprietary_name": "lansoprazole",
  "start_marketing_date": "20211210",
  "active_numerator_strength": "30"
}

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