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United States · US · US:43598-372_1ec57a05-1536-7b6a-a90e-3dd40c9f72d2
colchicine
Orange BookUNIISPLATC M04AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr.Reddys Laboratories, Inc.
CountryUS (United States)
ATC codeM04AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc114359837201100 TABLET in 1 BOTTLE (43598-372-01)
- ndc1143598372101000 TABLET in 1 BOTTLE (43598-372-10)
- ndc11435983723030 TABLET in 1 BOTTLE (43598-372-30)
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": "43598-372_1ec57a05-1536-7b6a-a90e-3dd40c9f72d2",
"productndc": "43598-372",
"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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