Home NDC 82867-001 LODOCO
Product NDC 82867-001
11-digit product format 828670001
Labeler code 82867
Product ID 82867-001_247fc59c-53cc-90da-e063-6394a90aac8d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Colchicine Tablets 0.5 mg
Dosage form TABLET
Route ORAL
Labeler AGEPHA Pharma USA, LLC
Application NDA215727
Marketing category NDA
Marketing start 2023-06-16
Substance COLCHICINE
Active strength .5 mg/1
Pharmacologic classes Alkaloid [EPC], Alkaloids [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215727-001 LODOCO COLCHICINE 0.5MG TABLET / ORAL RLD, RS 2023-06-16
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 a67488948f0b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 6 · 226 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N215727-001 10206891 2033-11-01 U-3641 2023-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215727-001 10265281 2033-11-01 U-3639 2023-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215727-001 10842762 2033-11-01 U-3640 2023-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215727-001 11026899 2033-11-01 U-3639 2023-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215727-001 11026900 2033-11-01 U-3639 2023-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215727-001 11026901 2033-11-01 U-3638 2023-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215727-001 11944594 2033-11-01 U-3864 2024-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215727-001 11944595 2033-11-01 U-3867 2024-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215727-001 11944595 2033-11-01 U-3868 2024-04-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215727-001 12233035 2033-11-01 U-4132 2025-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215727-001 12280025 2033-11-01 U-4168 2025-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215727-001 12364675 2033-11-01 U-3639 2025-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215727-001 9744144 2033-11-01 U-3643 2023-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215727-001 10130585 2034-05-09 U-3642 2023-06-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215727-001 10206891 2033-11-01 U-3641 2023-06-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215727-001 10265281 2033-11-01 U-3639 2023-06-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215727-001 10842762 2033-11-01 U-3640 2023-06-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215727-001 11026899 2033-11-01 U-3639 2023-06-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215727-001 11026900 2033-11-01 U-3639 2023-06-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215727-001 11026901 2033-11-01 U-3638 2023-06-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215727-001 11944594 2033-11-01 U-3864 2024-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215727-001 11944595 2033-11-01 U-3867 2024-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215727-001 11944595 2033-11-01 U-3868 2024-04-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215727-001 12233035 2033-11-01 U-4132 2025-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215727-001 12280025 2033-11-01 U-4168 2025-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215727-001 12364675 2033-11-01 U-3639 2025-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215727-001 9744144 2033-11-01 U-3643 2023-06-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215727-001 10130585 2034-05-09 U-3642 2023-06-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215727-001 10206891 2033-11-01 U-3641 2023-06-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215727-001 10265281 2033-11-01 U-3639 2023-06-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215727-001 10842762 2033-11-01 U-3640 2023-06-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215727-001 11026899 2033-11-01 U-3639 2023-06-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215727-001 11026900 2033-11-01 U-3639 2023-06-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215727-001 11026901 2033-11-01 U-3638 2023-06-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215727-001 11944594 2033-11-01 U-3864 2024-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215727-001 11944595 2033-11-01 U-3867 2024-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215727-001 11944595 2033-11-01 U-3868 2024-04-05 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215727-001 12233035 2033-11-01 U-4132 2025-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215727-001 12280025 2033-11-01 U-4168 2025-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215727-001 12364675 2033-11-01 U-3639 2025-07-23 6a471c1ec25d…
Additional Listing Data#
Finished product Yes
Brand name base LODOCO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength COLCHICINE .5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SML2Y3J35T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197540 Internal RxNorm lookup 2663988 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82867-001-01 LODOCO 30 in 1 BLISTER PACK TABLET 30 3 82867-001-01 LODOCO 1 in 1 CARTON TABLET 1 3 82867-001-02 LODOCO 1 in 1 CARTON TABLET 1 3 82867-001-02 LODOCO 30 in 1 BLISTER PACK TABLET 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82867-001 LODOCO (COLCHICINE TABLETS 0.5 MG) TABLET [AGEPHA PHARMA USA, LLC] 2 Current NDC, 4 package rows 20240828_ff06d68f-d65f-d097-e053-6294a90a7e5f.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join LODOCO COLCHICINE TABLETS 0.5 MG AGEPHA Pharma USA, LLC ff06d68f-d65f-d097-e053-6294a90a7e5f 2026-01-13 Warnings, Adverse reactions Exact identifier application applno (NDA): 215727 application number: NDA215727 ndc (product): 82867-001
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 82867-001-01 82867000101 1 BLISTER PACK in 1 CARTON (82867-001-01) / 30 TABLET in 1 BLISTER PACK 1 blister pack 2023-06-16 No No Current 82867-001-02 82867000102 1 BLISTER PACK in 1 CARTON (82867-001-02) / 30 TABLET in 1 BLISTER PACK 1 blister pack 2023-06-16 Yes No Current