colchicine

Generic: colchicine

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name colchicine
Generic Name colchicine
Labeler ascend laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

colchicine .6 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-589
Product ID 67877-589_498d5cac-62d7-4f25-b974-52b732abd789
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211250
Listing Expiration 2026-12-31
Marketing Start 2019-02-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877589
Hyphenated Format 67877-589

Supplemental Identifiers

RxCUI
197541
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 ANDA211250 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .6 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (67877-589-01)
  • 500 TABLET in 1 BOTTLE (67877-589-05)
  • 1000 TABLET in 1 BOTTLE (67877-589-10)
  • 30 TABLET in 1 BOTTLE (67877-589-30)
  • 1 BLISTER PACK in 1 CARTON (67877-589-33) / 10 TABLET in 1 BLISTER PACK
  • 60 TABLET in 1 BOTTLE (67877-589-60)
  • 3 BLISTER PACK in 1 CARTON (67877-589-84) / 10 TABLET in 1 BLISTER PACK
  • 250 TABLET in 1 BOTTLE (67877-589-86)
source: ndc

Packages (8)

67877-589-01 100 TABLET in 1 BOTTLE (67877-589-01) 67877-589-05 500 TABLET in 1 BOTTLE (67877-589-05) 67877-589-10 1000 TABLET in 1 BOTTLE (67877-589-10) 67877-589-30 30 TABLET in 1 BOTTLE (67877-589-30) 67877-589-33 1 BLISTER PACK in 1 CARTON (67877-589-33) / 10 TABLET in 1 BLISTER PACK 67877-589-60 60 TABLET in 1 BOTTLE (67877-589-60) 67877-589-84 3 BLISTER PACK in 1 CARTON (67877-589-84) / 10 TABLET in 1 BLISTER PACK 67877-589-86 250 TABLET in 1 BOTTLE (67877-589-86)

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": "498d5cac-62d7-4f25-b974-52b732abd789", "openfda": {"nui": ["N0000193949", "M0000713"], "unii": ["SML2Y3J35T"], "rxcui": ["197541"], "spl_set_id": ["a4284783-fea6-4af2-9a8d-79c929176c05"], "pharm_class_cs": ["Alkaloids [CS]"], "pharm_class_epc": ["Alkaloid [EPC]"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (67877-589-01)", "package_ndc": "67877-589-01", "marketing_start_date": "20190210"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (67877-589-05)", "package_ndc": "67877-589-05", "marketing_start_date": "20190210"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (67877-589-10)", "package_ndc": "67877-589-10", "marketing_start_date": "20190210"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (67877-589-30)", "package_ndc": "67877-589-30", "marketing_start_date": "20190210"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (67877-589-33)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "67877-589-33", "marketing_start_date": "20190210"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (67877-589-60)", "package_ndc": "67877-589-60", "marketing_start_date": "20190210"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (67877-589-84)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "67877-589-84", "marketing_start_date": "20190210"}, {"sample": false, "description": "250 TABLET in 1 BOTTLE (67877-589-86)", "package_ndc": "67877-589-86", "marketing_start_date": "20190210"}], "brand_name": "colchicine", "product_id": "67877-589_498d5cac-62d7-4f25-b974-52b732abd789", "dosage_form": "TABLET", "pharm_class": ["Alkaloid [EPC]", "Alkaloids [CS]"], "product_ndc": "67877-589", "generic_name": "colchicine", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "colchicine", "active_ingredients": [{"name": "COLCHICINE", "strength": ".6 mg/1"}], "application_number": "ANDA211250", "marketing_category": "ANDA", "marketing_start_date": "20190210", "listing_expiration_date": "20261231"}