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United States · US · US:71205-687_62a7d89d-9856-446f-aaa2-962825fef0a6
colchicine
Orange BookUNIISPLATC 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 · 6
- ndc1171205687055 TABLET in 1 BOTTLE (71205-687-05)
- ndc11712056871010 TABLET in 1 BOTTLE (71205-687-10)
- ndc11712056872121 TABLET in 1 BOTTLE (71205-687-21)
- ndc11712056873030 TABLET in 1 BOTTLE (71205-687-30)
- ndc11712056876060 TABLET in 1 BOTTLE (71205-687-60)
- ndc11712056879090 TABLET in 1 BOTTLE (71205-687-90)
Annotations
UNII (FDA Substance ID)
SML2Y3J35T
COLCHICINE
RxCUI 2683
Orange Book
A209876
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": "71205-687_62a7d89d-9856-446f-aaa2-962825fef0a6",
"productndc": "71205-687",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "209876",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.6MG",
"product_no": "001",
"approval_date": "Sep 6, 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": "ANDA209876",
"marketing_category": "ANDA",
"nonproprietary_name": "colchicine",
"start_marketing_date": "20200611",
"active_numerator_strength": ".6"
}Related drugs
Other records sharing ATC code M04AC01.
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