Home NDC 63629-2166 Colchicine
Product NDC 63629-2166
11-digit product format 636292166
Labeler code 63629
Product ID 63629-2166_294d20bb-a2cb-4175-9a2c-fb0aaa59264d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Colchicine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
Application NDA022352
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2018-07-01
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 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date N022352-001 COLCRYS COLCHICINE 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-29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 · 41 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 2026-02-19 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UTC 2026-02 N022352-001 COLCRYS 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2009-07-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022352-001 COLCRYS 0.6MG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…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022352-001 COLCRYS 0.6MG TABLET / ORAL AB RLD, RS 2009-07-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 18 · 697 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 N022352-001 7964647 2028-10-06 U-1007 2011-06-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022352-001 7964648 2028-10-06 U-1161 2011-06-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022352-001 7981938 2028-10-06 U-1166 2011-07-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022352-001 8093296 2028-10-06 U-1007 2012-01-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022352-001 8093297 2028-10-06 U-1161 2012-01-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022352-001 8093298 2028-10-06 U-1116 2012-01-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022352-001 8097655 2028-10-06 U-1020 2012-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022352-001 8415395 2028-10-06 U-1007 2013-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022352-001 8415396 2028-10-06 U-1007 2013-05-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022352-001 7619004 2028-12-03 U-1020 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022352-001 7935731 2028-12-03 U-1116 2011-06-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022352-001 7601758 2029-02-10 U-1007 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022352-001 7820681 2029-02-17 U-1020 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022352-001 7906519 2029-02-17 U-1116 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022352-001 7915269 2029-02-17 U-1007 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022352-001 8440721 2029-02-17 U-1007 2013-06-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022352-001 8440722 2029-02-17 U-1020 2013-06-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022352-001 7964647 2028-10-06 U-1007 2011-06-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022352-001 7964648 2028-10-06 U-1161 2011-06-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022352-001 7981938 2028-10-06 U-1166 2011-07-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022352-001 8093296 2028-10-06 U-1007 2012-01-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022352-001 8093297 2028-10-06 U-1161 2012-01-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022352-001 8093298 2028-10-06 U-1116 2012-01-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022352-001 8097655 2028-10-06 U-1020 2012-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022352-001 8415395 2028-10-06 U-1007 2013-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022352-001 8415396 2028-10-06 U-1007 2013-05-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022352-001 7619004 2028-12-03 U-1020 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022352-001 7935731 2028-12-03 U-1116 2011-06-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022352-001 7601758 2029-02-10 U-1007 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022352-001 7820681 2029-02-17 U-1020 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022352-001 7906519 2029-02-17 U-1116 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022352-001 7915269 2029-02-17 U-1007 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022352-001 8440721 2029-02-17 U-1007 2013-06-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022352-001 8440722 2029-02-17 U-1020 2013-06-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022352-001 7964647 2028-10-06 U-1007 2011-06-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022352-001 7964648 2028-10-06 U-1161 2011-06-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022352-001 7981938 2028-10-06 U-1166 2011-07-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022352-001 8093296 2028-10-06 U-1007 2012-01-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022352-001 8093297 2028-10-06 U-1161 2012-01-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022352-001 8093298 2028-10-06 U-1116 2012-01-13 6a471c1ec25d…
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 63629-2166-1 Colchicine 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 103
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63629-2166 COLCHICINE TABLET, FILM COATED [BRYANT RANCH PREPACK] 103 Current NDC, Legacy NDC, 1 package rows 20240111_5e5d9488-d9d0-4b37-b535-941d66c3430d.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 63629-2166-1 63629216601 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63629-2166-1) 2018-07-01 0000-00-00 No No Current