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United States · US · US:43598-109_12c603b4-a2cf-bfae-92c1-8b87a30e12ad

Lansoprazole

Orange BookUNIISPLATC A02BC03

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

Identification

ManufacturerDr. Reddy's Laboratories Inc.
CountryUS (United States)
ATC codeA02BC03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4359810927
    2 BOTTLE in 1 CARTON (43598-109-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • ndc11
    4359810933
    3 BOTTLE in 1 CARTON (43598-109-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • ndc11
    4359810952
    1 BOTTLE in 1 CARTON (43598-109-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
0K5C5T2QPG
LANSOPRAZOLE
RxCUI 17128
Orange Book
A202194
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": "43598-109_12c603b4-a2cf-bfae-92c1-8b87a30e12ad",
  "productndc": "43598-109",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "202194",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "May 18, 2012"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LANSOPRAZOLE",
  "proprietary_name": "Lansoprazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202194",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lansoprazole",
  "start_marketing_date": "20220412",
  "active_numerator_strength": "15"
}

Related drugs

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