Home NDC 82867-001-01 LODOCO
Product NDC 82867-001
Requested package NDC 82867-001-01
11-digit product format 828670001
Labeler code 82867
Product ID 82867-001_5e44d437-933c-3a09-e063-6394a90a4401
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 44 .
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 2026-10-15 13:18:30 2026-09 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 c2088c7a36db…2026-09-14 22:38:34 2026-08 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N215727-001 LODOCO 0.5MG TABLET / ORAL RLD, RS 2023-06-16 caaa826d4ba7…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 7 · 268 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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