colchicine

Generic: colchicine

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name colchicine
Generic Name colchicine
Labeler amneal pharmaceuticals llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

colchicine .6 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-710
Product ID 65162-710_74974eef-499f-456f-8683-da23bb0c1137
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204711
Listing Expiration 2026-12-31
Marketing Start 2016-09-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162710
Hyphenated Format 65162-710

Supplemental Identifiers

RxCUI
197541
UPC
0365162710113
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 colchicine (source: ndc)
Generic Name colchicine (source: ndc)
Application Number ANDA204711 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .6 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (65162-710-03)
  • 90 TABLET in 1 BOTTLE (65162-710-09)
  • 1000 TABLET in 1 BOTTLE (65162-710-11)
source: ndc

Packages (3)

65162-710-03 30 TABLET in 1 BOTTLE (65162-710-03) 65162-710-09 90 TABLET in 1 BOTTLE (65162-710-09) 65162-710-11 1000 TABLET in 1 BOTTLE (65162-710-11)

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": "74974eef-499f-456f-8683-da23bb0c1137", "openfda": {"nui": ["N0000193949", "M0000713"], "upc": ["0365162710113"], "unii": ["SML2Y3J35T"], "rxcui": ["197541"], "spl_set_id": ["7daef7e2-888d-4116-81a9-2c02b9ef97ef"], "pharm_class_cs": ["Alkaloids [CS]"], "pharm_class_epc": ["Alkaloid [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (65162-710-03)", "package_ndc": "65162-710-03", "marketing_start_date": "20160930"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (65162-710-09)", "package_ndc": "65162-710-09", "marketing_start_date": "20160930"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (65162-710-11)", "package_ndc": "65162-710-11", "marketing_start_date": "20160930"}], "brand_name": "Colchicine", "product_id": "65162-710_74974eef-499f-456f-8683-da23bb0c1137", "dosage_form": "TABLET", "pharm_class": ["Alkaloid [EPC]", "Alkaloids [CS]"], "product_ndc": "65162-710", "generic_name": "Colchicine", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Colchicine", "active_ingredients": [{"name": "COLCHICINE", "strength": ".6 mg/1"}], "application_number": "ANDA204711", "marketing_category": "ANDA", "marketing_start_date": "20160930", "listing_expiration_date": "20261231"}