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United States · US · US:72162-1855_ced96216-1841-40f8-939a-6627f2d7079a
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
- ndc117216218551100 TABLET in 1 BOTTLE (72162-1855-1)
Annotations
UNII (FDA Substance ID)
SML2Y3J35T
COLCHICINE
RxCUI 2683
Orange Book
A211250
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": "72162-1855_ced96216-1841-40f8-939a-6627f2d7079a",
"productndc": "72162-1855",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211250",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.6MG",
"product_no": "001",
"approval_date": "Feb 8, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "COLCHICINE",
"proprietary_name": "colchicine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211250",
"marketing_category": "ANDA",
"nonproprietary_name": "colchicine",
"start_marketing_date": "20190210",
"active_numerator_strength": ".6"
}Related drugs
Other records sharing ATC code M04AC01.
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