mitigare

Generic: colchicine

Labeler: hikma specialty usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name mitigare
Generic Name colchicine
Labeler hikma specialty usa inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

colchicine .6 mg/1

Manufacturer
Hikma Specialty USA Inc.

Identifiers & Regulatory

Product NDC 59467-318
Product ID 59467-318_14dc4aa3-a989-41f6-9dd4-86f5490dc152
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA204820
Listing Expiration 2026-12-31
Marketing Start 2014-10-01

Pharmacologic Class

Established (EPC)
alkaloid [epc]
Chemical Structure
alkaloids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59467318
Hyphenated Format 59467-318

Supplemental Identifiers

RxCUI
1550940 1550946
UNII
SML2Y3J35T
NUI
N0000193949 M0000713

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name mitigare (source: ndc)
Generic Name colchicine (source: ndc)
Application Number NDA204820 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .6 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (59467-318-01)
  • 1000 CAPSULE in 1 BOTTLE (59467-318-10)
  • 30 CAPSULE in 1 BOTTLE (59467-318-30)
source: ndc

Packages (3)

59467-318-01 100 CAPSULE in 1 BOTTLE (59467-318-01) 59467-318-10 1000 CAPSULE in 1 BOTTLE (59467-318-10) 59467-318-30 30 CAPSULE in 1 BOTTLE (59467-318-30)

Ingredients (1)

colchicine (.6 mg/1)

Linked Drug Pages (1)

MITIGARE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "14dc4aa3-a989-41f6-9dd4-86f5490dc152", "openfda": {"nui": ["N0000193949", "M0000713"], "unii": ["SML2Y3J35T"], "rxcui": ["1550940", "1550946"], "spl_set_id": ["cb5f9d85-6b81-49f8-bcd6-17b7bfbc10f2"], "pharm_class_cs": ["Alkaloids [CS]"], "pharm_class_epc": ["Alkaloid [EPC]"], "manufacturer_name": ["Hikma Specialty USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (59467-318-01)", "package_ndc": "59467-318-01", "marketing_start_date": "20141001"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (59467-318-10)", "package_ndc": "59467-318-10", "marketing_start_date": "20141001"}, {"sample": false, "description": "30 CAPSULE in 1 BOTTLE (59467-318-30)", "package_ndc": "59467-318-30", "marketing_start_date": "20180726"}], "brand_name": "MITIGARE", "product_id": "59467-318_14dc4aa3-a989-41f6-9dd4-86f5490dc152", "dosage_form": "CAPSULE", "pharm_class": ["Alkaloid [EPC]", "Alkaloids [CS]"], "product_ndc": "59467-318", "generic_name": "Colchicine", "labeler_name": "Hikma Specialty USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MITIGARE", "active_ingredients": [{"name": "COLCHICINE", "strength": ".6 mg/1"}], "application_number": "NDA204820", "marketing_category": "NDA", "marketing_start_date": "20141001", "listing_expiration_date": "20261231"}