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United States · US · US:82867-001_247fc59c-53cc-90da-e063-6394a90aac8d
LODOCO
Orange BookUNIISPLATC M04AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAGEPHA Pharma USA, LLC
CountryUS (United States)
ATC codeM04AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1182867001011 BLISTER PACK in 1 CARTON (82867-001-01) / 30 TABLET in 1 BLISTER PACK
- ndc1182867001021 BLISTER PACK in 1 CARTON (82867-001-02) / 30 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
SML2Y3J35T
COLCHICINE
RxCUI 2683
Orange Book
N215727
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": {
"ff06d68f-d65f-d097-e053-6294a90a7e5f": {
"match": "brand_token",
"title": "LODOCO (COLCHICINE TABLETS 0.5 MG) TABLET [AGEPHA PHARMA USA, LLC]",
"spl_version": "3",
"published_date": "2026-01-14"
}
},
"productid": "82867-001_247fc59c-53cc-90da-e063-6394a90aac8d",
"productndc": "82867-001",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "215727",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "0.5MG",
"product_no": "001",
"approval_date": "Jun 16, 2023"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "COLCHICINE",
"proprietary_name": "LODOCO",
"active_ingred_unit": "mg/1",
"application_number": "NDA215727",
"marketing_category": "NDA",
"nonproprietary_name": "Colchicine Tablets 0.5 mg",
"start_marketing_date": "20230616",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code M04AC01.
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