lodoco

Generic: colchicine tablets 0.5 mg

Labeler: agepha pharma usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name lodoco
Generic Name colchicine tablets 0.5 mg
Labeler agepha pharma usa, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

colchicine .5 mg/1

Manufacturer
AGEPHA Pharma USA, LLC

Identifiers & Regulatory

Product NDC 82867-001
Product ID 82867-001_247fc59c-53cc-90da-e063-6394a90aac8d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215727
Listing Expiration 2027-12-31
Marketing Start 2023-06-16

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82867001
Hyphenated Format 82867-001

Supplemental Identifiers

RxCUI
197540 2663988
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 lodoco (source: ndc)
Generic Name colchicine tablets 0.5 mg (source: ndc)
Application Number NDA215727 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (82867-001-01) / 30 TABLET in 1 BLISTER PACK
  • 1 BLISTER PACK in 1 CARTON (82867-001-02) / 30 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

82867-001-01 1 BLISTER PACK in 1 CARTON (82867-001-01) / 30 TABLET in 1 BLISTER PACK 82867-001-02 1 BLISTER PACK in 1 CARTON (82867-001-02) / 30 TABLET in 1 BLISTER PACK

Ingredients (1)

colchicine (.5 mg/1)

Linked Drug Pages (1)

LODOCO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "247fc59c-53cc-90da-e063-6394a90aac8d", "openfda": {"nui": ["N0000193949", "M0000713"], "unii": ["SML2Y3J35T"], "rxcui": ["197540", "2663988"], "spl_set_id": ["ff06d68f-d65f-d097-e053-6294a90a7e5f"], "pharm_class_cs": ["Alkaloids [CS]"], "pharm_class_epc": ["Alkaloid [EPC]"], "manufacturer_name": ["AGEPHA Pharma USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (82867-001-01)  / 30 TABLET in 1 BLISTER PACK", "package_ndc": "82867-001-01", "marketing_start_date": "20230616"}, {"sample": true, "description": "1 BLISTER PACK in 1 CARTON (82867-001-02)  / 30 TABLET in 1 BLISTER PACK", "package_ndc": "82867-001-02", "marketing_start_date": "20230616"}], "brand_name": "LODOCO", "product_id": "82867-001_247fc59c-53cc-90da-e063-6394a90aac8d", "dosage_form": "TABLET", "pharm_class": ["Alkaloid [EPC]", "Alkaloids [CS]"], "product_ndc": "82867-001", "generic_name": "Colchicine Tablets 0.5 mg", "labeler_name": "AGEPHA Pharma USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LODOCO", "active_ingredients": [{"name": "COLCHICINE", "strength": ".5 mg/1"}], "application_number": "NDA215727", "marketing_category": "NDA", "marketing_start_date": "20230616", "listing_expiration_date": "20271231"}