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United States · US · US:0143-3018_76a875b0-99ff-4f9a-9113-ad5e122b7a79
Colchicine
Orange BookUNIISPLATC M04AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Pharmaceuticals USA Inc.
CountryUS (United States)
ATC codeM04AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc110143301801100 CAPSULE in 1 BOTTLE, PLASTIC (0143-3018-01)
- ndc1101433018101000 CAPSULE in 1 BOTTLE, PLASTIC (0143-3018-10)
- ndc11014330183030 CAPSULE in 1 BOTTLE, PLASTIC (0143-3018-30)
Annotations
UNII (FDA Substance ID)
SML2Y3J35T
COLCHICINE
RxCUI 2683
Orange Book
N204820
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": "0143-3018_76a875b0-99ff-4f9a-9113-ad5e122b7a79",
"productndc": "0143-3018",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "204820",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.6MG",
"product_no": "001",
"approval_date": "Sep 26, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "COLCHICINE",
"proprietary_name": "Colchicine",
"active_ingred_unit": "mg/1",
"application_number": "NDA204820",
"marketing_category": "NDA",
"nonproprietary_name": "Colchicine",
"start_marketing_date": "20141001",
"active_numerator_strength": ".6"
}Related drugs
Other records sharing ATC code M04AC01.
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