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United States · US · US:43598-459_bdfcecdc-5523-2091-0405-62d51c91e287

Trientine Hydrochloride

Orange BookUNIISPLATC A16AX12

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

Identification

ManufacturerDr.Reddys Laboratories Inc
CountryUS (United States)
ATC codeA16AX12
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4359845901
    100 CAPSULE in 1 BOTTLE (43598-459-01)

Annotations

UNII (FDA Substance ID)
HC3NX54582
TRIENTINE HYDROCHLORIDE
RxCUI 235370
Orange Book
A211076
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": "43598-459_bdfcecdc-5523-2091-0405-62d51c91e287",
  "productndc": "43598-459",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "211076",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Jul 3, 2019"
      }
    ],
    "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": "ANDA211076",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Trientine Hydrochloride",
  "start_marketing_date": "20190703",
  "active_numerator_strength": "250"
}

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