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United States · US · US:71610-494_543ae21a-60f3-49e2-8bad-b9ee0f412235
Colchicine
Orange BookUNIISPLATC M04AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeM04AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1171610494039 TABLET, FILM COATED in 1 BOTTLE (71610-494-03)
Annotations
UNII (FDA Substance ID)
SML2Y3J35T
COLCHICINE
RxCUI 2683
Orange Book
A210425
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": "71610-494_543ae21a-60f3-49e2-8bad-b9ee0f412235",
"productndc": "71610-494",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "210425",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.6MG",
"product_no": "001",
"approval_date": "Feb 5, 2020"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "COLCHICINE",
"proprietary_name": "Colchicine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210425",
"marketing_category": "ANDA",
"nonproprietary_name": "Colchicine",
"start_marketing_date": "20200205",
"active_numerator_strength": ".6"
}Related drugs
Other records sharing ATC code M04AC01.
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