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United States · US · US:25010-705_08d38e76-baa2-473a-9b7c-18a4d9b96f9a

Cuprimine

Orange BookUNIISPLATC M01CC01

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

Identification

ManufacturerBausch Health US, LLC
CountryUS (United States)
ATC codeM01CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    2501070515
    100 CAPSULE in 1 BOTTLE (25010-705-15)

Annotations

UNII (FDA Substance ID)
GNN1DV99GX
PENICILLAMINE
RxCUI 7975
Orange Book
N019853
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "GNN1DV99GX",
    "rxcui": "7975",
    "inchikey": "VVNCNSJFMMFHPL-VKHMYHEASA-N",
    "display_name": "PENICILLAMINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "80e736d3-2017-4d68-94b4-38255c3c59c6": {
      "match": "brand_token",
      "title": "CUPRIMINE (PENICILLAMINE) CAPSULE [BAUSCH HEALTH US, LLC]",
      "spl_version": "17",
      "published_date": "2026-01-28"
    }
  },
  "productid": "25010-705_08d38e76-baa2-473a-9b7c-18a4d9b96f9a",
  "productndc": "25010-705",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "019853",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "125MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PENICILLAMINE",
  "proprietary_name": "Cuprimine",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA019853",
  "marketing_category": "NDA",
  "nonproprietary_name": "penicillamine",
  "start_marketing_date": "19701204",
  "active_numerator_strength": "250"
}

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