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United States · US · US:70771-1396_9bfd545b-8ea3-4758-b6dc-fff2e9af14ee
Colchicine
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerZydus Lifesciences Limited
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1170771139611 BOTTLE in 1 CARTON (70771-1396-1) / 100 TABLET in 1 BOTTLE
- ndc1170771139631 BOTTLE in 1 CARTON (70771-1396-3) / 30 TABLET in 1 BOTTLE
- ndc1170771139651 BOTTLE in 1 CARTON (70771-1396-5) / 500 TABLET in 1 BOTTLE
- ndc1170771139691 BOTTLE in 1 CARTON (70771-1396-9) / 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": "70771-1396_9bfd545b-8ea3-4758-b6dc-fff2e9af14ee",
"productndc": "70771-1396",
"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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