colchicine

Generic: colchicine

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name colchicine
Generic Name colchicine
Labeler chartwell rx, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

colchicine .6 mg/1

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-789
Product ID 62135-789_459c796b-4b43-354e-e063-6294a90a7dec
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209173
Listing Expiration 2026-12-31
Marketing Start 2023-03-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 62135789
Hyphenated Format 62135-789

Supplemental Identifiers

RxCUI
197541
UPC
0362135789305 0362135789909
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 ANDA209173 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .6 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (62135-789-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (62135-789-90)
source: ndc

Packages (2)

62135-789-30 30 TABLET, FILM COATED in 1 BOTTLE (62135-789-30) 62135-789-90 90 TABLET, FILM COATED in 1 BOTTLE (62135-789-90)

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": "459c796b-4b43-354e-e063-6294a90a7dec", "openfda": {"nui": ["N0000193949", "M0000713"], "upc": ["0362135789305", "0362135789909"], "unii": ["SML2Y3J35T"], "rxcui": ["197541"], "spl_set_id": ["16d8e0f4-567d-4de1-ac25-6e2527f1d58e"], "pharm_class_cs": ["Alkaloids [CS]"], "pharm_class_epc": ["Alkaloid [EPC]"], "manufacturer_name": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (62135-789-30)", "package_ndc": "62135-789-30", "marketing_start_date": "20231027"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (62135-789-90)", "package_ndc": "62135-789-90", "marketing_start_date": "20231027"}], "brand_name": "Colchicine", "product_id": "62135-789_459c796b-4b43-354e-e063-6294a90a7dec", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Alkaloid [EPC]", "Alkaloids [CS]"], "product_ndc": "62135-789", "generic_name": "Colchicine", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Colchicine", "active_ingredients": [{"name": "COLCHICINE", "strength": ".6 mg/1"}], "application_number": "ANDA209173", "marketing_category": "ANDA", "marketing_start_date": "20230326", "listing_expiration_date": "20261231"}