colchicine

Generic: colchicine

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name colchicine
Generic Name colchicine
Labeler endo usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

colchicine .6 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 0254-0460
Product ID 0254-0460_735839a2-f0c1-4ce2-b8ae-a0d281d76e09
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208678
Listing Expiration 2026-12-31
Marketing Start 2023-11-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 02540460
Hyphenated Format 0254-0460

Supplemental Identifiers

RxCUI
1550940
UPC
0302540460017
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 ANDA208678 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .6 mg/1
source: ndc
Packaging
  • 100 CAPSULE in 1 BOTTLE (0254-0460-01)
source: ndc

Packages (1)

0254-0460-01 100 CAPSULE in 1 BOTTLE (0254-0460-01)

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": "735839a2-f0c1-4ce2-b8ae-a0d281d76e09", "openfda": {"nui": ["N0000193949", "M0000713"], "upc": ["0302540460017"], "unii": ["SML2Y3J35T"], "rxcui": ["1550940"], "spl_set_id": ["eb509994-6ecc-4599-b87a-98495fef6129"], "pharm_class_cs": ["Alkaloids [CS]"], "pharm_class_epc": ["Alkaloid [EPC]"], "manufacturer_name": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 CAPSULE in 1 BOTTLE (0254-0460-01)", "package_ndc": "0254-0460-01", "marketing_start_date": "20231101"}], "brand_name": "Colchicine", "product_id": "0254-0460_735839a2-f0c1-4ce2-b8ae-a0d281d76e09", "dosage_form": "CAPSULE", "pharm_class": ["Alkaloid [EPC]", "Alkaloids [CS]"], "product_ndc": "0254-0460", "generic_name": "Colchicine", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Colchicine", "active_ingredients": [{"name": "COLCHICINE", "strength": ".6 mg/1"}], "application_number": "ANDA208678", "marketing_category": "ANDA", "marketing_start_date": "20231101", "listing_expiration_date": "20261231"}