colchicine

Generic: colchicine

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name colchicine
Generic Name colchicine
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

colchicine .6 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-494
Product ID 71610-494_543ae21a-60f3-49e2-8bad-b9ee0f412235
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210425
Listing Expiration 2026-12-31
Marketing Start 2020-02-05

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610494
Hyphenated Format 71610-494

Supplemental Identifiers

RxCUI
197541
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 ANDA210425 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .6 mg/1
source: ndc
Packaging
  • 9 TABLET, FILM COATED in 1 BOTTLE (71610-494-03)
source: ndc

Packages (1)

71610-494-03 9 TABLET, FILM COATED in 1 BOTTLE (71610-494-03)

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": "543ae21a-60f3-49e2-8bad-b9ee0f412235", "openfda": {"nui": ["N0000193949", "M0000713"], "unii": ["SML2Y3J35T"], "rxcui": ["197541"], "spl_set_id": ["b310c57c-9192-4dc8-b76f-2c1982941caf"], "pharm_class_cs": ["Alkaloids [CS]"], "pharm_class_epc": ["Alkaloid [EPC]"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "9 TABLET, FILM COATED in 1 BOTTLE (71610-494-03)", "package_ndc": "71610-494-03", "marketing_start_date": "20201117"}], "brand_name": "Colchicine", "product_id": "71610-494_543ae21a-60f3-49e2-8bad-b9ee0f412235", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Interactions [MoA]"], "product_ndc": "71610-494", "generic_name": "Colchicine", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Colchicine", "active_ingredients": [{"name": "COLCHICINE", "strength": ".6 mg/1"}], "application_number": "ANDA210425", "marketing_category": "ANDA", "marketing_start_date": "20200205", "listing_expiration_date": "20261231"}