Prevacid SoluTab

Orange BookUNIISPLATC A02BC03

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

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
6476454405
5 BLISTER PACK in 1 TRAY (64764-544-05) / 3 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK
ndc11
6476454411
10 BLISTER PACK in 1 CARTON (64764-544-11) / 10 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK (64764-544-30)

Annotations

UNII (FDA Substance ID)

0K5C5T2QPG

LANSOPRAZOLE

RxCUI 17128

Orange Book

N021428

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": {
    "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": "64764-544_45f1d5ff-d884-4e40-a16c-313a4e21e32c",
  "productndc": "64764-544",
  "dosage_form": "TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "021428",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "15MG",
        "product_no": "001",
        "approval_date": "Aug 30, 2002"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Aug 30, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LANSOPRAZOLE",
  "proprietary_name": "Prevacid SoluTab",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021428",
  "marketing_category": "NDA",
  "nonproprietary_name": "lansoprazole",
  "start_marketing_date": "20020830",
  "active_numerator_strength": "30"
}

Related drugs

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