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United States · US · US:16571-810_96619f61-e1f2-4ed3-9a81-c05077c8cbcb

Trientine Hydrochloride

Orange BookUNIISPLATC A16AX12

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

Identification

ManufacturerRising Pharma Holdings, Inc.
CountryUS (United States)
ATC codeA16AX12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    1657181001
    100 CAPSULE in 1 BOTTLE (16571-810-01)

Annotations

UNII (FDA Substance ID)
HC3NX54582
TRIENTINE HYDROCHLORIDE
RxCUI 235370
Orange Book
A212238
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "HC3NX54582",
    "rxcui": "235370",
    "inchikey": "WYHIICXRPHEJKI-UHFFFAOYSA-N",
    "display_name": "TRIENTINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "431c7f66-d58b-4eb0-b195-d164788f9acf": {
      "match": "brand_token",
      "title": "TRIENTINE HYDROCHLORIDE CAPSULE [PAR HEALTH USA, LLC]",
      "spl_version": "10",
      "published_date": "2026-05-06"
    }
  },
  "productid": "16571-810_96619f61-e1f2-4ed3-9a81-c05077c8cbcb",
  "productndc": "16571-810",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "212238",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Feb 20, 2020"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "500MG",
        "product_no": "002",
        "approval_date": "Sep 22, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TRIENTINE HYDROCHLORIDE",
  "proprietary_name": "Trientine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA212238",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Trientine Hydrochloride",
  "start_marketing_date": "20210330",
  "active_numerator_strength": "250"
}

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