Home NDC 72189-249 COLCHICINE
Product NDC 72189-249
11-digit product format 721890249
Labeler code 72189
Product ID 72189-249_2c28c181-51d4-7164-e063-6394a90a1d0c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name COLCHICINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler direct rx
Application NDA022352
Marketing category NDA
Marketing start 2021-07-23
Substance COLCHICINE
Active strength .6 mg/1
Pharmacologic classes Alkaloid [EPC], Alkaloids [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72189-249-03 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72189-249-03 0efc9e666f02…f202fb6c5f17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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date N022352-001 COLCRYS COLCHICINE 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-29
Orange Book patents# Current patent rows page 1 of 1 · 17 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.
Product history page 1 of 2 · 42 observed 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 2026-08-18 06:07:40 2026-07 N022352-001 COLCRYS 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022352-001 COLCRYS 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022352-001 COLCRYS 0.6MG TABLET / ORAL RLD 2009-07-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022352-001 COLCRYS 0.6MG TABLET / ORAL RLD 2009-07-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022352-001 COLCRYS 0.6MG TABLET / ORAL RLD 2009-07-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022352-001 COLCRYS 0.6MG TABLET / ORAL RLD 2009-07-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022352-001 COLCRYS 0.6MG TABLET / ORAL RLD 2009-07-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022352-001 COLCRYS 0.6MG TABLET / ORAL RLD 2009-07-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022352-001 COLCRYS 0.6MG TABLET / ORAL RLD 2009-07-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022352-001 COLCRYS 0.6MG TABLET / ORAL RLD 2009-07-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022352-001 COLCRYS 0.6MG TABLET / ORAL RLD 2009-07-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022352-001 COLCRYS 0.6MG TABLET / ORAL RLD 2009-07-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022352-001 COLCRYS 0.6MG TABLET / ORAL RLD 2009-07-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022352-001 COLCRYS 0.6MG TABLET / ORAL RLD 2009-07-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 18 · 714 observed states.
Additional Listing Data#
Finished product Yes
Brand name base COLCHICINE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength COLCHICINE .6 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197541 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 72189-249-03 COLCHICINE 3 in 1 BOTTLE TABLET, FILM COATED 3 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72189-249 COLCHICINE TABLET, FILM COATED [DIRECT RX] 2 Current NDC, Legacy NDC, 1 package rows 20250121_c7d013b7-0a67-0953-e053-2a95a90ac47c.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 · 5 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 72189-249-03 72189024903 3 TABLET, FILM COATED in 1 BOTTLE (72189-249-03) 2021-07-23 0000-00-00 No No Current