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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
- ndc11048078249890 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"
}Related drugs
Other records sharing ATC code G04BX16.
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