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United States · US · US:72162-2239_e2456b53-466f-4dbc-bd4a-e21d5e487303

Dexlansoprazole

Orange BookUNIISPLATC A02BC06

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeA02BC06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7216222393
    30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72162-2239-3)
  • ndc11
    7216222399
    90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72162-2239-9)

Annotations

UNII (FDA Substance ID)
UYE4T5I70X
DEXLANSOPRAZOLE
RxCUI 816346
Orange Book
A202666
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": "72162-2239_e2456b53-466f-4dbc-bd4a-e21d5e487303",
  "productndc": "72162-2239",
  "dosage_form": "CAPSULE, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "202666",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "001",
        "approval_date": "Sep 16, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "60MG",
        "product_no": "002",
        "approval_date": "Sep 16, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXLANSOPRAZOLE",
  "proprietary_name": "Dexlansoprazole",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202666",
  "marketing_category": "ANDA",
  "nonproprietary_name": "dexlansoprazole",
  "start_marketing_date": "20221201",
  "active_numerator_strength": "60"
}

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