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United States · US · US:71335-2791_e4d9651d-0570-418b-8a5e-c3d2b99bb3c5
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 · 9
- ndc11713352791130 TABLET, FILM COATED in 1 BOTTLE (71335-2791-1)
- ndc11713352791220 TABLET, FILM COATED in 1 BOTTLE (71335-2791-2)
- ndc1171335279133 TABLET, FILM COATED in 1 BOTTLE (71335-2791-3)
- ndc11713352791412 TABLET, FILM COATED in 1 BOTTLE (71335-2791-4)
- ndc1171335279156 TABLET, FILM COATED in 1 BOTTLE (71335-2791-5)
- ndc1171335279169 TABLET, FILM COATED in 1 BOTTLE (71335-2791-6)
- ndc11713352791715 TABLET, FILM COATED in 1 BOTTLE (71335-2791-7)
- ndc11713352791810 TABLET, FILM COATED in 1 BOTTLE (71335-2791-8)
- ndc11713352791990 TABLET, FILM COATED in 1 BOTTLE (71335-2791-9)
Annotations
UNII (FDA Substance ID)
SML2Y3J35T
COLCHICINE
RxCUI 2683
Orange Book
A208993
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": "71335-2791_e4d9651d-0570-418b-8a5e-c3d2b99bb3c5",
"productndc": "71335-2791",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "208993",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.6MG",
"product_no": "001",
"approval_date": "Aug 13, 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": "ANDA208993",
"marketing_category": "ANDA",
"nonproprietary_name": "Colchicine",
"start_marketing_date": "20210813",
"active_numerator_strength": ".6"
}Related drugs
Other records sharing ATC code M04AC01.
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