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United States · US · US:42571-341_4b1291c8-4d59-6a18-e063-6294a90a2526
Colchicine
Orange BookUNIISPLATC M04AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeM04AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc114257134101100 CAPSULE in 1 BOTTLE (42571-341-01)
- ndc1142571341101000 CAPSULE in 1 BOTTLE (42571-341-10)
- ndc11425713413030 CAPSULE in 1 BOTTLE (42571-341-30)
Annotations
UNII (FDA Substance ID)
SML2Y3J35T
COLCHICINE
RxCUI 2683
Orange Book
A212880
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": {
"68d4bf2b-8e2c-4621-aa08-463f43e253c3": {
"match": "brand_token",
"title": "COLCHICINE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]",
"spl_version": "2",
"published_date": "2026-05-22"
}
},
"productid": "42571-341_4b1291c8-4d59-6a18-e063-6294a90a2526",
"productndc": "42571-341",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "212880",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.6MG",
"product_no": "001",
"approval_date": "Feb 17, 2026"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "COLCHICINE",
"proprietary_name": "Colchicine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA212880",
"marketing_category": "ANDA",
"nonproprietary_name": "Colchicine",
"start_marketing_date": "20260218",
"active_numerator_strength": ".6"
}Related drugs
Other records sharing ATC code M04AC01.
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