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United States · US · US:33342-341_9111bbad-b020-44fb-b276-d7853e5acd2c
Colchicine
Orange BookUNIISPLATC M04AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMacleods Pharmaceuticals Limited
CountryUS (United States)
ATC codeM04AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11333423410730 TABLET in 1 BOTTLE (33342-341-07)
- ndc113334234111100 TABLET in 1 BOTTLE (33342-341-11)
- ndc113334234115500 TABLET in 1 BOTTLE (33342-341-15)
- ndc11333423414211 BLISTER PACK in 1 CARTON (33342-341-42) / 10 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
SML2Y3J35T
COLCHICINE
RxCUI 2683
Orange Book
A210633
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": "33342-341_9111bbad-b020-44fb-b276-d7853e5acd2c",
"productndc": "33342-341",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "210633",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.6MG",
"product_no": "001",
"approval_date": "Feb 13, 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": "ANDA210633",
"marketing_category": "ANDA",
"nonproprietary_name": "Colchicine",
"start_marketing_date": "20170424",
"active_numerator_strength": ".6"
}Related drugs
Other records sharing ATC code M04AC01.
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