Back to search
🇺🇸

United States · US · US:0037-4401_d5cb9986-f53c-4f8c-acb9-d5bdff6f07b2

Depen

Orange BookUNIISPLATC M01CC01

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

Identification

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

Packs · 1

  • ndc11
    0037440101
    100 TABLET in 1 BOTTLE (0037-4401-01)

Annotations

UNII (FDA Substance ID)
GNN1DV99GX
PENICILLAMINE
RxCUI 7975
Orange Book
N019854
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": {
    "38f8ae60-b354-11de-8a39-0800200c9a66": {
      "match": "brand_token",
      "title": "DEPEN (PENICILLAMINE) TABLET [VIATRIS SPECIALTY LLC]",
      "spl_version": "8",
      "published_date": "2025-12-08"
    }
  },
  "productid": "0037-4401_d5cb9986-f53c-4f8c-acb9-d5bdff6f07b2",
  "productndc": "0037-4401",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "019854",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "250MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PENICILLAMINE",
  "proprietary_name": "Depen",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA019854",
  "marketing_category": "NDA",
  "nonproprietary_name": "Penicillamine",
  "start_marketing_date": "19781130",
  "active_numerator_strength": "250"
}

Related drugs

Other records sharing ATC code M01CC01.

Access this data programmatically

Query Depen and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.