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United States · US · US:63629-8362_3f922884-7115-4509-b5f9-1e93563be69f
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
- ndc11636298362130 TABLET in 1 BOTTLE (63629-8362-1)
- ndc11636298362220 TABLET in 1 BOTTLE (63629-8362-2)
- ndc1163629836233 TABLET in 1 BOTTLE (63629-8362-3)
- ndc11636298362412 TABLET in 1 BOTTLE (63629-8362-4)
- ndc1163629836256 TABLET in 1 BOTTLE (63629-8362-5)
- ndc1163629836269 TABLET in 1 BOTTLE (63629-8362-6)
- ndc11636298362715 TABLET in 1 BOTTLE (63629-8362-7)
- ndc11636298362810 TABLET in 1 BOTTLE (63629-8362-8)
- ndc11636298362990 TABLET in 1 BOTTLE (63629-8362-9)
Annotations
UNII (FDA Substance ID)
SML2Y3J35T
COLCHICINE
RxCUI 2683
Orange Book
A211250
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": "63629-8362_3f922884-7115-4509-b5f9-1e93563be69f",
"productndc": "63629-8362",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211250",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.6MG",
"product_no": "001",
"approval_date": "Feb 8, 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": "ANDA211250",
"marketing_category": "ANDA",
"nonproprietary_name": "colchicine",
"start_marketing_date": "20190210",
"active_numerator_strength": ".6"
}Related drugs
Other records sharing ATC code M04AC01.
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