Lansoprazole

Orange BookUNIISPLATC A02BC03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerPreferred Pharmaceuticals Inc.

CountryUS (United States)

ATC codeA02BC03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
6878863901
100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6390-1)
ndc11
6878863902
20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6390-2)
ndc11
6878863903
30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6390-3)
ndc11
6878863904
14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6390-4)
ndc11
6878863906
60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6390-6)
ndc11
6878863907
40 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6390-7)
ndc11
6878863908
120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6390-8)
ndc11
6878863909
90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-6390-9)

Annotations

UNII (FDA Substance ID)

0K5C5T2QPG

LANSOPRAZOLE

RxCUI 17128

Orange Book

A091269

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": "68788-6390_0f526740-dba7-4ef4-8832-634aca7d65ad",
  "productndc": "68788-6390",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "091269",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Oct 15, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Oct 15, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LANSOPRAZOLE",
  "proprietary_name": "Lansoprazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091269",
  "marketing_category": "ANDA",
  "nonproprietary_name": "lansoprazole",
  "start_marketing_date": "20160520",
  "active_numerator_strength": "15"
}

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