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United States · US · US:80830-2301_0483ece7-d1e5-4787-a73e-1b41c75f26a7

CUPRIC CHLORIDE

Orange BookUNIISPL

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

Identification

ManufacturerAmneal Pharmaceuticals Private Limited
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8083023015
    25 VIAL in 1 CARTON (80830-2301-5) / 10 mL in 1 VIAL (80830-2301-1)

Annotations

UNII (FDA Substance ID)
S2QG84156O
CUPRIC CHLORIDE
RxCUI 21833
Orange Book
A217287
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "S2QG84156O",
    "rxcui": "21833",
    "inchikey": "MPTQRFCYZCXJFQ-UHFFFAOYSA-L",
    "display_name": "CUPRIC CHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "86bb8a4d-6896-4901-9390-c9a194b6f0cb": {
      "match": "brand_token",
      "title": "CUPRIC CHLORIDE INJECTION, SOLUTION [RENOVA PHARMACEUTICALS LLC]",
      "spl_version": "2",
      "published_date": "2026-05-11"
    }
  },
  "productid": "80830-2301_0483ece7-d1e5-4787-a73e-1b41c75f26a7",
  "productndc": "80830-2301",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "217287",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.4MG COPPER/ML",
        "product_no": "001",
        "approval_date": "Jan 26, 2026"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CUPRIC CHLORIDE",
  "proprietary_name": "CUPRIC CHLORIDE",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA217287",
  "marketing_category": "ANDA",
  "nonproprietary_name": "CUPRIC CHLORIDE",
  "start_marketing_date": "20260129",
  "active_numerator_strength": ".4"
}

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