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United States · US · US:70710-1351_cf874687-3377-4fd3-9616-6c1f74454ad3
Colchicine
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Pharmaceuticals USA Inc.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1170710135111 BOTTLE in 1 CARTON (70710-1351-1) / 100 TABLET in 1 BOTTLE
- ndc1170710135131 BOTTLE in 1 CARTON (70710-1351-3) / 30 TABLET in 1 BOTTLE
- ndc1170710135151 BOTTLE in 1 CARTON (70710-1351-5) / 500 TABLET in 1 BOTTLE
- ndc1170710135191 BOTTLE in 1 CARTON (70710-1351-9) / 90 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
HJ30158L57
COLCHICEINE
RxCUI 2174385
Orange Book
A211519
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "HJ30158L57",
"rxcui": "2174385",
"inchikey": "PRGILOMAMBLWNG-HNNXBMFYSA-N",
"display_name": "COLCHICEINE",
"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": "70710-1351_cf874687-3377-4fd3-9616-6c1f74454ad3",
"productndc": "70710-1351",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211519",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.6MG",
"product_no": "001",
"approval_date": "Feb 19, 2019"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "0.3MG",
"product_no": "002",
"approval_date": "Nov 14, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "COLCHICEINE",
"proprietary_name": "Colchicine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA211519",
"marketing_category": "ANDA",
"nonproprietary_name": "Colchicine",
"start_marketing_date": "20190612",
"active_numerator_strength": ".6"
}Access this data programmatically
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