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United States · US · US:16714-039_b510d002-4c8e-4b5e-bc76-c49552e79d45
Colchicine
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNorthstar Rx LLC.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1116714039011 BOTTLE in 1 CARTON (16714-039-01) / 30 TABLET in 1 BOTTLE
- ndc1116714039021 BOTTLE in 1 CARTON (16714-039-02) / 100 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": "16714-039_b510d002-4c8e-4b5e-bc76-c49552e79d45",
"productndc": "16714-039",
"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": "20201110",
"active_numerator_strength": ".6"
}Access this data programmatically
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