🇺🇸
United States · US · US:59467-318_14dc4aa3-a989-41f6-9dd4-86f5490dc152
MITIGARE
Orange BookUNIISPLATC M04AC01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHikma Specialty USA Inc.
CountryUS (United States)
ATC codeM04AC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc115946731801100 CAPSULE in 1 BOTTLE (59467-318-01)
- ndc1159467318101000 CAPSULE in 1 BOTTLE (59467-318-10)
- ndc11594673183030 CAPSULE in 1 BOTTLE (59467-318-30)
Annotations
UNII (FDA Substance ID)
SML2Y3J35T
COLCHICINE
RxCUI 2683
Orange Book
N204820
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": {
"cb5f9d85-6b81-49f8-bcd6-17b7bfbc10f2": {
"match": "brand_token",
"title": "MITIGARE (COLCHICINE) CAPSULE [HIKMA SPECIALTY USA INC.]",
"spl_version": "18",
"published_date": "2024-05-23"
}
},
"productid": "59467-318_14dc4aa3-a989-41f6-9dd4-86f5490dc152",
"productndc": "59467-318",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "204820",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "0.6MG",
"product_no": "001",
"approval_date": "Sep 26, 2014"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "COLCHICINE",
"proprietary_name": "MITIGARE",
"active_ingred_unit": "mg/1",
"application_number": "NDA204820",
"marketing_category": "NDA",
"nonproprietary_name": "Colchicine",
"start_marketing_date": "20141001",
"active_numerator_strength": ".6"
}Related drugs
Other records sharing ATC code M04AC01.
Access this data programmatically
Query MITIGARE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.