Tralement

Orange BookUNIISPL

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAmerican Regent, Inc.

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0517930525
25 VIAL, SINGLE-DOSE in 1 TRAY (0517-9305-25) / 1 mL in 1 VIAL, SINGLE-DOSE (0517-9305-01)

Annotations

UNII (FDA Substance ID)

LRX7AJ16DT

CUPRIC SULFATE

RxCUI 21579

Orange Book

N209376

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "LRX7AJ16DT",
    "rxcui": "21579",
    "inchikey": "JZCCFEFSEZPSOG-UHFFFAOYSA-L",
    "display_name": "CUPRIC SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "a49ffb90-f307-433e-a86e-aaea6d6a9982": {
      "match": "brand_token",
      "title": "TRALEMENT (TRACE ELEMENTS INJECTION 4) INJECTION, SOLUTION [AMERICAN REGENT, INC.]",
      "spl_version": "9",
      "published_date": "2024-08-26"
    }
  },
  "productid": "0517-9305_4a6d8c5d-729c-45b3-b565-2e10e0cbcaaf",
  "productndc": "0517-9305",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "209376",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)",
        "product_no": "001",
        "approval_date": "Jul 2, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)",
        "product_no": "002",
        "approval_date": "Dec 2, 2020"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML)",
        "product_no": "003",
        "approval_date": "Jun 30, 2021"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE",
  "proprietary_name": "Tralement",
  "active_ingred_unit": "mg/mL; ug/mL; ug/mL; mg/mL",
  "application_number": "NDA209376",
  "marketing_category": "NDA",
  "nonproprietary_name": "Trace Elements Injection 4",
  "start_marketing_date": "20200929",
  "active_numerator_strength": ".3; 55; 60; 3"
}

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