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United States · US · US:68391-823_0ad7d69d-29af-43c5-81a6-6f370591ef9f

BERKLEY AND JENSEN LANSOPRAZOLE

Orange BookUNIISPLATC A02BC03

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

Identification

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

Packs · 1

  • ndc11
    6839182303
    3 BOTTLE in 1 PACKAGE (68391-823-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68391-823-00)

Annotations

UNII (FDA Substance ID)
0K5C5T2QPG
LANSOPRAZOLE
RxCUI 17128
Orange Book
A202319
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": {
    "cda57e42-6106-46ee-82d1-479a692ee5bb": {
      "match": "brand_token",
      "title": "BERKLEY AND JENSEN IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [BJWC]",
      "spl_version": "9",
      "published_date": "2026-05-25"
    }
  },
  "productid": "68391-823_0ad7d69d-29af-43c5-81a6-6f370591ef9f",
  "productndc": "68391-823",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "202319",
    "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": "BERKLEY AND JENSEN LANSOPRAZOLE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202319",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Lansoprazole",
  "start_marketing_date": "20221021",
  "active_numerator_strength": "15"
}

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