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United States · US · US:63187-292_db4b884e-dd04-4097-83fe-a42f171bf9a5
Colcrys
Orange BookUNIIATC M04AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeM04AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1163187292033 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63187-292-03)
Annotations
UNII (FDA Substance ID)
SML2Y3J35T
COLCHICINE
RxCUI 2683
Orange Book
N022352
Raw payload (JSON)
{
"unii": {
"unii": "SML2Y3J35T",
"rxcui": "2683",
"inchikey": "IAKHMKGGTNLKSZ-INIZCTEOSA-N",
"display_name": "COLCHICINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"productid": "63187-292_db4b884e-dd04-4097-83fe-a42f171bf9a5",
"productndc": "63187-292",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "022352",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
"product_no": "001",
"approval_date": "Jul 29, 2009"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "COLCHICINE",
"proprietary_name": "Colcrys",
"active_ingred_unit": "mg/1",
"application_number": "NDA022352",
"marketing_category": "NDA",
"nonproprietary_name": "Colchicine",
"start_marketing_date": "20090901",
"active_numerator_strength": ".6"
}Related drugs
Other records sharing ATC code M04AC01.
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