colchicine

Generic: colchicine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name colchicine
Generic Name colchicine
Labeler aurobindo pharma limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

colchicine .6 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-455
Product ID 59651-455_eedd0f18-16dc-4404-bc85-507ec93049e9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215444
Listing Expiration 2026-12-31
Marketing Start 2022-03-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651455
Hyphenated Format 59651-455

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 ANDA215444 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .6 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (59651-455-01)
  • 30 TABLET in 1 BOTTLE (59651-455-30)
source: ndc

Packages (2)

59651-455-01 100 TABLET in 1 BOTTLE (59651-455-01) 59651-455-30 30 TABLET in 1 BOTTLE (59651-455-30)

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": "eedd0f18-16dc-4404-bc85-507ec93049e9", "openfda": {"nui": ["N0000193949", "M0000713"], "unii": ["SML2Y3J35T"], "rxcui": ["197541"], "spl_set_id": ["dd93a40f-92ab-47ac-9083-b8a7a0b18ad6"], "pharm_class_cs": ["Alkaloids [CS]"], "pharm_class_epc": ["Alkaloid [EPC]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (59651-455-01)", "package_ndc": "59651-455-01", "marketing_start_date": "20220322"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (59651-455-30)", "package_ndc": "59651-455-30", "marketing_start_date": "20220322"}], "brand_name": "Colchicine", "product_id": "59651-455_eedd0f18-16dc-4404-bc85-507ec93049e9", "dosage_form": "TABLET", "pharm_class": ["Alkaloid [EPC]", "Alkaloids [CS]"], "product_ndc": "59651-455", "generic_name": "Colchicine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Colchicine", "active_ingredients": [{"name": "COLCHICINE", "strength": ".6 mg/1"}], "application_number": "ANDA215444", "marketing_category": "ANDA", "marketing_start_date": "20220322", "listing_expiration_date": "20261231"}