colchicine

Generic: colchicine

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

colchicine .6 mg/1

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-1086
Product ID 0378-1086_9ba74921-d6b7-40a8-aa1e-d7431574a137
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209470
Listing Expiration 2026-12-31
Marketing Start 2019-11-25

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03781086
Hyphenated Format 0378-1086

Supplemental Identifiers

RxCUI
197541
UPC
0303781086936
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 ANDA209470 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .6 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1086-01)
source: ndc

Packages (1)

0378-1086-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1086-01)

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": "9ba74921-d6b7-40a8-aa1e-d7431574a137", "openfda": {"nui": ["N0000193949", "M0000713"], "upc": ["0303781086936"], "unii": ["SML2Y3J35T"], "rxcui": ["197541"], "spl_set_id": ["85acf34c-06c6-40ea-95f4-060d5de99277"], "pharm_class_cs": ["Alkaloids [CS]"], "pharm_class_epc": ["Alkaloid [EPC]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1086-01)", "package_ndc": "0378-1086-01", "marketing_start_date": "20191125"}], "brand_name": "Colchicine", "product_id": "0378-1086_9ba74921-d6b7-40a8-aa1e-d7431574a137", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Alkaloid [EPC]", "Alkaloids [CS]"], "product_ndc": "0378-1086", "generic_name": "Colchicine", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Colchicine", "active_ingredients": [{"name": "COLCHICINE", "strength": ".6 mg/1"}], "application_number": "ANDA209470", "marketing_category": "ANDA", "marketing_start_date": "20191125", "listing_expiration_date": "20261231"}