🇺🇸
United States · US · US:63629-2166_294d20bb-a2cb-4175-9a2c-fb0aaa59264d
Colchicine
Orange BookUNIISPLATC M04AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeM04AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116362921661100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-2166-1)
Annotations
UNII (FDA Substance ID)
SML2Y3J35T
COLCHICINE
RxCUI 2683
Orange Book
N022352
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": "63629-2166_294d20bb-a2cb-4175-9a2c-fb0aaa59264d",
"productndc": "63629-2166",
"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"strength": "0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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": "Colchicine",
"active_ingred_unit": "mg/1",
"application_number": "NDA022352",
"marketing_category": "NDA AUTHORIZED GENERIC",
"nonproprietary_name": "Colchicine",
"start_marketing_date": "20180701",
"active_numerator_strength": ".6"
}Related drugs
Other records sharing ATC code M04AC01.
Access this data programmatically
Query Colchicine and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.