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United States · US · US:50742-263_8f0d4438-1ba8-419c-864f-b95cb0b006ef
Probenecid and Colchicine
Orange BookUNIISPLATC M04AC
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerIngenus Pharmaceuticals, LLC
CountryUS (United States)
ATC codeM04AC
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115074226301100 TABLET in 1 BOTTLE (50742-263-01)
Annotations
UNII (FDA Substance ID)
SML2Y3J35T
COLCHICINE
RxCUI 2683
Orange Book
A040618
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "SML2Y3J35T",
"rxcui": "2683",
"inchikey": "IAKHMKGGTNLKSZ-INIZCTEOSA-N",
"display_name": "COLCHICINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"65b4888c-d49a-433f-9bfd-17880ae40069": {
"match": "brand_token",
"title": "PROBENECID TABLET [REMEDYREPACK INC.]",
"spl_version": "1",
"published_date": "2026-04-30"
}
},
"productid": "50742-263_8f0d4438-1ba8-419c-864f-b95cb0b006ef",
"productndc": "50742-263",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "040618",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.5MG;500MG",
"product_no": "001",
"approval_date": "May 13, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "COLCHICINE; PROBENECID",
"proprietary_name": "Probenecid and Colchicine",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA040618",
"marketing_category": "ANDA",
"nonproprietary_name": "Probenecid and Colchicine",
"start_marketing_date": "20190516",
"active_numerator_strength": ".5; 500"
}Related drugs
Other records sharing ATC code M04AC.
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