colchicine

Generic: colchicine

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name colchicine
Generic Name colchicine
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

colchicine .6 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7120
Product ID 0904-7120_7542e468-1c98-45ea-9aa2-153bdb40b663
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210425
Listing Expiration 2026-12-31
Marketing Start 2020-05-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047120
Hyphenated Format 0904-7120

Supplemental Identifiers

RxCUI
197541
UNII
SML2Y3J35T
NUI
N0000193949 M0000713

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 ANDA210425 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .6 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0904-7120-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7120-04 30 BLISTER PACK in 1 CARTON (0904-7120-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "7542e468-1c98-45ea-9aa2-153bdb40b663", "openfda": {"nui": ["N0000193949", "M0000713"], "unii": ["SML2Y3J35T"], "rxcui": ["197541"], "spl_set_id": ["9e7c8f65-4722-4187-9014-8fa81eb5681e"], "pharm_class_cs": ["Alkaloids [CS]"], "pharm_class_epc": ["Alkaloid [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-7120-04)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-7120-04", "marketing_start_date": "20200513"}], "brand_name": "Colchicine", "product_id": "0904-7120_7542e468-1c98-45ea-9aa2-153bdb40b663", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Alkaloid [EPC]", "Alkaloids [CS]"], "product_ndc": "0904-7120", "generic_name": "Colchicine", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Colchicine", "active_ingredients": [{"name": "COLCHICINE", "strength": ".6 mg/1"}], "application_number": "ANDA210425", "marketing_category": "ANDA", "marketing_start_date": "20200513", "listing_expiration_date": "20261231"}