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United States · US · US:50090-5944_275745bb-b010-45d6-9541-78d365e2dd46

Dexlansoprazole

Orange BookUNIISPLATC A02BC06

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeA02BC06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5009059440
    30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5944-0)
  • ndc11
    5009059441
    90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-5944-1)

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": {
    "8dca4887-c75a-4021-8564-b704e9e1fa3e": {
      "match": "brand_token",
      "title": "DEXLANSOPRAZOLE DELAYED RELEASE (DEXLANSOPRAZOLE) CAPSULE, DELAYED RELEASE [UPSHER-SMITH LABORATORIES, LLC]",
      "spl_version": "9",
      "published_date": "2026-06-02"
    }
  },
  "productid": "50090-5944_275745bb-b010-45d6-9541-78d365e2dd46",
  "productndc": "50090-5944",
  "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": "Dexlansoprazole",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA022287",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "dexlansoprazole",
  "start_marketing_date": "20220101",
  "active_numerator_strength": "60"
}

Related drugs

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