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United States · US · US:64764-171_402fdd3a-6183-4a0d-85ac-61d4221fc921

Dexilant

Orange BookUNIISPLATC A02BC06

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

Identification

ManufacturerTakeda Pharmaceuticals America, Inc.
CountryUS (United States)
ATC codeA02BC06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    6476417100
    7 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-171-00)
  • ndc11
    6476417101
    5 BLISTER PACK in 1 TRAY (64764-171-01) / 4 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
  • ndc11
    6476417103
    1 BOTTLE in 1 CARTON (64764-171-03) / 5 CAPSULE, DELAYED RELEASE in 1 BOTTLE
  • ndc11
    6476417111
    10 BLISTER PACK in 1 CARTON (64764-171-11) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK
  • ndc11
    6476417119
    1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-171-19)
  • ndc11
    6476417130
    30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-171-30)
  • ndc11
    6476417190
    90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (64764-171-90)

Annotations

UNII (FDA Substance ID)
UYE4T5I70X
DEXLANSOPRAZOLE
RxCUI 816346
Orange Book
N022287
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "UYE4T5I70X",
    "rxcui": "816346",
    "inchikey": "MJIHNNLFOKEZEW-RUZDIDTESA-N",
    "display_name": "DEXLANSOPRAZOLE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "9819f033-3bbe-442e-8e92-45fec77b237d": {
      "match": "brand_token",
      "title": "DEXILANT (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [TAKEDA PHARMACEUTICALS AMERICA, INC.]",
      "spl_version": "40",
      "published_date": "2025-02-24"
    }
  },
  "productid": "64764-171_402fdd3a-6183-4a0d-85ac-61d4221fc921",
  "productndc": "64764-171",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "022287",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Jan 30, 2009"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "002",
        "approval_date": "Jan 30, 2009"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXLANSOPRAZOLE",
  "proprietary_name": "Dexilant",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022287",
  "marketing_category": "NDA",
  "nonproprietary_name": "dexlansoprazole",
  "start_marketing_date": "20100412",
  "active_numerator_strength": "30"
}

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