colcrys

Generic: colchicine

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name colcrys
Generic Name colchicine
Labeler takeda pharmaceuticals america, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

colchicine .6 mg/1

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 64764-119
Product ID 64764-119_6f7b50e5-99b4-45e8-90d4-6aa8fc54a5a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022352
Marketing Start 2009-09-01
Marketing End 2026-04-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64764119
Hyphenated Format 64764-119

Supplemental Identifiers

RxCUI
197541 858071
UPC
0364764119072
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 colcrys (source: ndc)
Generic Name colchicine (source: ndc)
Application Number NDA022352 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .6 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-01)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-06)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-07)
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-10)
source: ndc

Packages (4)

64764-119-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-01) 64764-119-06 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-06) 64764-119-07 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-07) 64764-119-10 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-10)

Ingredients (1)

colchicine (.6 mg/1)

Linked Drug Pages (1)

Colcrys ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6f7b50e5-99b4-45e8-90d4-6aa8fc54a5a4", "openfda": {"nui": ["N0000193949", "M0000713"], "upc": ["0364764119072"], "unii": ["SML2Y3J35T"], "rxcui": ["197541", "858071"], "spl_set_id": ["56c130d1-7581-4152-99a2-0014ee9366c0"], "pharm_class_cs": ["Alkaloids [CS]"], "pharm_class_epc": ["Alkaloid [EPC]"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-01)", "package_ndc": "64764-119-01", "marketing_end_date": "20260430", "marketing_start_date": "20090901"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-06)", "package_ndc": "64764-119-06", "marketing_end_date": "20260430", "marketing_start_date": "20090901"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-07)", "package_ndc": "64764-119-07", "marketing_end_date": "20260430", "marketing_start_date": "20090901"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-10)", "package_ndc": "64764-119-10", "marketing_end_date": "20260430", "marketing_start_date": "20090901"}], "brand_name": "Colcrys", "product_id": "64764-119_6f7b50e5-99b4-45e8-90d4-6aa8fc54a5a4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Alkaloid [EPC]", "Alkaloids [CS]"], "product_ndc": "64764-119", "generic_name": "Colchicine", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Colcrys", "active_ingredients": [{"name": "COLCHICINE", "strength": ".6 mg/1"}], "application_number": "NDA022352", "marketing_category": "NDA", "marketing_end_date": "20260430", "marketing_start_date": "20090901"}