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 TABLET, FILM COATED
Routes
ORAL
Active Ingredients

colchicine .6 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 49884-171
Product ID 49884-171_d13b21fd-9c53-4776-aff7-3e140a71b273
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203976
Listing Expiration 2026-12-31
Marketing Start 2022-09-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49884171
Hyphenated Format 49884-171

Supplemental Identifiers

RxCUI
197541
UPC
0349884171117
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 ANDA203976 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .6 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (49884-171-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (49884-171-11)
source: ndc

Packages (2)

49884-171-01 100 TABLET, FILM COATED in 1 BOTTLE (49884-171-01) 49884-171-11 30 TABLET, FILM COATED in 1 BOTTLE (49884-171-11)

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": "d13b21fd-9c53-4776-aff7-3e140a71b273", "openfda": {"nui": ["N0000193949", "M0000713"], "upc": ["0349884171117"], "unii": ["SML2Y3J35T"], "rxcui": ["197541"], "spl_set_id": ["72984aa2-6df9-4460-9926-399ffed30e36"], "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 TABLET, FILM COATED in 1 BOTTLE (49884-171-01)", "package_ndc": "49884-171-01", "marketing_start_date": "20220927"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (49884-171-11)", "package_ndc": "49884-171-11", "marketing_start_date": "20220927"}], "brand_name": "Colchicine", "product_id": "49884-171_d13b21fd-9c53-4776-aff7-3e140a71b273", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Alkaloid [EPC]", "Alkaloids [CS]"], "product_ndc": "49884-171", "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": "ANDA203976", "marketing_category": "ANDA", "marketing_start_date": "20220927", "listing_expiration_date": "20261231"}