Lansoprazole

Orange BookUNIISPLATC A02BC03

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

Identification

ManufacturerDr.Reddys Laboratories Inc

CountryUS (United States)

ATC codeA02BC03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4359856178
100 BLISTER PACK in 1 CARTON (43598-561-78) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (43598-561-79)

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": "43598-561_9d1837b8-8381-eef1-3cc8-a1738b66b5d6",
  "productndc": "43598-561",
  "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": "20210201",
  "active_numerator_strength": "30"
}

Related drugs

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