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United States · US · US:49884-171_7503eeb8-f535-4686-b18b-b2d2f61d82a5
Colchicine
Orange BookUNIISPLATC M04AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPar Health USA, LLC
CountryUS (United States)
ATC codeM04AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc114988417101100 TABLET, FILM COATED in 1 BOTTLE (49884-171-01)
- ndc11498841711130 TABLET, FILM COATED in 1 BOTTLE (49884-171-11)
Annotations
UNII (FDA Substance ID)
SML2Y3J35T
COLCHICINE
RxCUI 2683
Orange Book
A203976
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": "49884-171_7503eeb8-f535-4686-b18b-b2d2f61d82a5",
"productndc": "49884-171",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "203976",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB",
"strength": "0.6MG",
"product_no": "001",
"approval_date": "Aug 12, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "COLCHICINE",
"proprietary_name": "Colchicine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203976",
"marketing_category": "ANDA",
"nonproprietary_name": "colchicine",
"start_marketing_date": "20220927",
"active_numerator_strength": ".6"
}Related drugs
Other records sharing ATC code M04AC01.
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