colchicine

Generic: colchicine

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name colchicine
Generic Name colchicine
Labeler coupler llc
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

colchicine .6 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1634
Product ID 67046-1634_486f5e01-4fc0-6f5c-e063-6394a90a19f8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217620
Listing Expiration 2027-12-31
Marketing Start 2025-12-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 670461634
Hyphenated Format 67046-1634

Supplemental Identifiers

RxCUI
1550940
UNII
SML2Y3J35T
NUI
N0000193949 M0000713

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 colchicine (source: ndc)
Generic Name colchicine (source: ndc)
Application Number ANDA217620 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .6 mg/1
source: ndc
Packaging
  • 30 CAPSULE in 1 BLISTER PACK (67046-1634-3)
source: ndc

Packages (1)

67046-1634-3 30 CAPSULE in 1 BLISTER PACK (67046-1634-3)

Ingredients (1)

colchicine (.6 mg/1)

Linked Drug Pages (1)

COLCHICINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "486f5e01-4fc0-6f5c-e063-6394a90a19f8", "openfda": {"nui": ["N0000193949", "M0000713"], "unii": ["SML2Y3J35T"], "rxcui": ["1550940"], "spl_set_id": ["472ec026-c755-ae02-e063-6394a90af0c6"], "pharm_class_cs": ["Alkaloids [CS]"], "pharm_class_epc": ["Alkaloid [EPC]"], "manufacturer_name": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE in 1 BLISTER PACK (67046-1634-3)", "package_ndc": "67046-1634-3", "marketing_start_date": "20251230"}], "brand_name": "COLCHICINE", "product_id": "67046-1634_486f5e01-4fc0-6f5c-e063-6394a90a19f8", "dosage_form": "CAPSULE", "pharm_class": ["Alkaloid [EPC]", "Alkaloids [CS]"], "product_ndc": "67046-1634", "generic_name": "COLCHICINE", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "COLCHICINE", "active_ingredients": [{"name": "COLCHICINE", "strength": ".6 mg/1"}], "application_number": "ANDA217620", "marketing_category": "ANDA", "marketing_start_date": "20251230", "listing_expiration_date": "20271231"}