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United States · US · US:68475-201_0ee5ea02-a892-408f-aa5d-42ab034bdfc4

Penicillamine

Orange BookUNIISPLATC M01CC01

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

Identification

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

Packs · 1

  • ndc11
    6847520101
    100 CAPSULE in 1 BOTTLE (68475-201-01)

Annotations

UNII (FDA Substance ID)
GNN1DV99GX
PENICILLAMINE
RxCUI 7975
Orange Book
A214363
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": {
    "594d7a82-af1d-41c4-98ee-0ea6895fc237": {
      "match": "brand_token",
      "title": "PENICILLAMINE CAPSULE [ACTAVIS PHARMA, INC.]",
      "spl_version": "4",
      "published_date": "2025-08-15"
    }
  },
  "productid": "68475-201_0ee5ea02-a892-408f-aa5d-42ab034bdfc4",
  "productndc": "68475-201",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "214363",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Oct 8, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PENICILLAMINE",
  "proprietary_name": "Penicillamine",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214363",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Penicillamine",
  "start_marketing_date": "20220101",
  "active_numerator_strength": "250"
}

Related drugs

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