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United States · US · US:0054-0668_89b02f3c-d8da-4b1f-9847-859c4efffabb

Alvimopan

Orange BookUNIISPLATC A06AH02

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

Identification

ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeA06AH02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0054066882
    6 BLISTER PACK in 1 CARTON (0054-0668-82) / 5 CAPSULE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
677C126AET
ALVIMOPAN
RxCUI 480639
Orange Book
A217753
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "677C126AET",
    "rxcui": "480639",
    "inchikey": "USPVLEIQIUNQGE-DBFLIVQGSA-N",
    "display_name": "ALVIMOPAN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "1cd584de-b704-4d26-8451-e3247ffb8d08": {
      "match": "brand_token",
      "title": "ALVIMOPAN CAPSULE [PAR HEALTH USA, LLC]",
      "spl_version": "12",
      "published_date": "2026-04-23"
    }
  },
  "productid": "0054-0668_89b02f3c-d8da-4b1f-9847-859c4efffabb",
  "productndc": "0054-0668",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "217753",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "12MG",
        "product_no": "001",
        "approval_date": "Aug 31, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ALVIMOPAN",
  "proprietary_name": "Alvimopan",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA217753",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Alvimopan",
  "start_marketing_date": "20240206",
  "active_numerator_strength": "12"
}

Related drugs

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