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United States · US · US:62332-823_c75e1427-f24f-46ab-8a19-29069bc6ca2e

Dexlansoprazole

Orange BookUNIISPLATC A02BC06

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

Identification

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

Packs · 2

  • ndc11
    6233282330
    30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-823-30)
  • ndc11
    6233282390
    90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62332-823-90)

Annotations

UNII (FDA Substance ID)
UYE4T5I70X
DEXLANSOPRAZOLE
RxCUI 816346
Orange Book
A219115
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": "62332-823_c75e1427-f24f-46ab-8a19-29069bc6ca2e",
  "productndc": "62332-823",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "219115",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Nov 12, 2025"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "002",
        "approval_date": "Nov 12, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXLANSOPRAZOLE",
  "proprietary_name": "Dexlansoprazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA219115",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Dexlansoprazole",
  "start_marketing_date": "20251114",
  "active_numerator_strength": "30"
}

Related drugs

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