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United States · US · US:67046-1634_486f5e01-4fc0-6f5c-e063-6394a90a19f8
COLCHICINE
Orange BookUNIISPLATC M04AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCoupler LLC
CountryUS (United States)
ATC codeM04AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11670461634330 CAPSULE in 1 BLISTER PACK (67046-1634-3)
Annotations
UNII (FDA Substance ID)
SML2Y3J35T
COLCHICINE
RxCUI 2683
Orange Book
A217620
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": "67046-1634_486f5e01-4fc0-6f5c-e063-6394a90a19f8",
"productndc": "67046-1634",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "217620",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.6MG",
"product_no": "001",
"approval_date": "Apr 29, 2024"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "COLCHICINE",
"proprietary_name": "COLCHICINE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA217620",
"marketing_category": "ANDA",
"nonproprietary_name": "COLCHICINE",
"start_marketing_date": "20251230",
"active_numerator_strength": ".6"
}Related drugs
Other records sharing ATC code M04AC01.
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