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United States · US · US:70709-123_c8eeb4d4-9718-41ba-b4fe-3d645fd60a20

VENXXIVA

Orange BookUNIISPLATC G04BX16

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

Identification

ManufacturerCycle Pharmaceuticals Ltd.
CountryUS (United States)
ATC codeG04BX16
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7070912390
    90 TABLET, DELAYED RELEASE in 1 BOTTLE (70709-123-90)

Annotations

UNII (FDA Substance ID)
C5W04GO61S
TIOPRONIN
RxCUI 6765
Orange Book
A216990
ABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "C5W04GO61S",
    "rxcui": "6765",
    "inchikey": "YTGJWQPHMWSCST-UHFFFAOYSA-N",
    "display_name": "TIOPRONIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "02e24443-04c6-4b98-a395-49aec4a468de": {
      "match": "brand_token",
      "title": "VENXXIVA (TIOPRONIN) TABLET, DELAYED RELEASE [CYCLE PHARMACEUTICALS LTD.]",
      "spl_version": "2",
      "published_date": "2025-12-23"
    }
  },
  "productid": "70709-123_c8eeb4d4-9718-41ba-b4fe-3d645fd60a20",
  "productndc": "70709-123",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "216990",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jan 30, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Jan 30, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIOPRONIN",
  "proprietary_name": "VENXXIVA",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216990",
  "marketing_category": "ANDA",
  "nonproprietary_name": "tiopronin",
  "start_marketing_date": "20250122",
  "active_numerator_strength": "300"
}

Related drugs

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