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United States · US · US:0480-7824_53891a64-8014-4b0b-9f13-cfc3d90166b2

Tiopronin

Orange BookUNIISPLATC G04BX16

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

Identification

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

Packs · 1

  • ndc11
    0480782498
    90 TABLET, DELAYED RELEASE in 1 BOTTLE (0480-7824-98)

Annotations

UNII (FDA Substance ID)
C5W04GO61S
TIOPRONIN
RxCUI 6765
Orange Book
A216456
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": {
    "ce5b1f97-5b3c-40b6-b1c4-1d36025be1b8": {
      "match": "brand_token",
      "title": "TIOPRONIN TABLET, DELAYED RELEASE [AMNEAL PHARMACEUTICALS NY LLC]",
      "spl_version": "8",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0480-7824_53891a64-8014-4b0b-9f13-cfc3d90166b2",
  "productndc": "0480-7824",
  "dosage_form": "TABLET, DELAYED RELEASE",
  "orange_book": {
    "appl_no": "216456",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jul 22, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "300MG",
        "product_no": "002",
        "approval_date": "Jul 22, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TIOPRONIN",
  "proprietary_name": "Tiopronin",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA216456",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tiopronin",
  "start_marketing_date": "20241008",
  "active_numerator_strength": "300"
}

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