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United States · US · US:64764-046_45f1d5ff-d884-4e40-a16c-313a4e21e32c

Prevacid

Orange BookUNIISPLATC A02BC03

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

Identification

ManufacturerTakeda Pharmaceuticals America, Inc.
CountryUS (United States)
ATC codeA02BC03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6476404606
    5 BLISTER PACK in 1 TRAY (64764-046-06) / 4 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
  • ndc11
    6476404613
    100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-046-13)

Annotations

UNII (FDA Substance ID)
0K5C5T2QPG
LANSOPRAZOLE
RxCUI 17128
Orange Book
N020406
AB
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": {
    "71ba78cb-7e46-43eb-9425-fa130f537f84": {
      "match": "brand_token",
      "title": "PREVACID (LANSOPRAZOLE) CAPSULE, DELAYED RELEASE PREVACID SOLUTAB (LANSOPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "45",
      "published_date": "2025-07-18"
    }
  },
  "productid": "64764-046_45f1d5ff-d884-4e40-a16c-313a4e21e32c",
  "productndc": "64764-046",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "020406",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "May 10, 1995"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "May 10, 1995"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LANSOPRAZOLE",
  "proprietary_name": "Prevacid",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020406",
  "marketing_category": "NDA",
  "nonproprietary_name": "lansoprazole",
  "start_marketing_date": "19950510",
  "active_numerator_strength": "30"
}

Related drugs

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