Colchicine

Product NDC: 0254-2008
11-digit product format: 002542008
Labeler code: 0254
Product ID: 0254-2008_bd7a3243-fb43-40fa-8a57-81c063d79a8a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Colchicine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Par Pharmaceutical, Inc.
Application: NDA022352
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2018-07-01
Marketing end: 0000-00-00
Substance: COLCHICINE
Active strength: 1 mg/1
Pharmacologic classes: Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA],Alkaloid [EPC],Alkaloids [CS]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0254-2008		I	Inactivated by FDA	2026-08-11
excluded package	package	0254-2008	0254-2008-01	I	Inactivated by FDA	2026-08-11
excluded package	package	0254-2008	0254-2008-11	I	Inactivated by FDA	2026-08-11

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 · 27 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0254-2008-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0254-2008-11	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0254-2008-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0254-2008-11	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0254-2008-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0254-2008-11	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0254-2008-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0254-2008-11	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0254-2008-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0254-2008-11	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0254-2008-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0254-2008-11	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0254-2008-11	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0254-2008-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0254-2008-11	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0254-2008-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0254-2008-11	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0254-2008-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N022352-001	7964647	2028-10-06	U-1007	2011-06-24
N022352-001	7964648	2028-10-06	U-1161	2011-06-24
N022352-001	7981938	2028-10-06	U-1166	2011-07-22
N022352-001	8093296	2028-10-06	U-1007	2012-01-13
N022352-001	8093297	2028-10-06	U-1161	2012-01-13
N022352-001	8093298	2028-10-06	U-1116	2012-01-13
N022352-001	8097655	2028-10-06	U-1020	2012-01-27
N022352-001	8415395	2028-10-06	U-1007	2013-05-08
N022352-001	8415396	2028-10-06	U-1007	2013-05-08
N022352-001	7619004	2028-12-03	U-1020
N022352-001	7935731	2028-12-03	U-1116	2011-06-24
N022352-001	7601758	2029-02-10	U-1007
N022352-001	7820681	2029-02-17	U-1020
N022352-001	7906519	2029-02-17	U-1116
N022352-001	7915269	2029-02-17	U-1007
N022352-001	8440721	2029-02-17	U-1007	2013-06-10
N022352-001	8440722	2029-02-17	U-1020	2013-06-10

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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	N022352-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022352-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022352-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022352-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022352-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022352-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022352-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022352-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022352-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022352-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022352-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022352-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022352-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022352-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022352-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022352-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022352-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022352-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022352-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022352-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022352-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022352-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022352-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022352-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022352-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022352-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022352-001	AB	1	`cb3db0bc1861…`

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	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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
51989a2b-944a-b31f-835e-469c133570ad	Product name	2	20250716
11e940b0-77bd-45d4-a80f-028ff6bd67e2	Product name	2	20250214
14efe2b0-2695-4943-8b2f-24f519c99fed	Product name	1	20231023
bf4e8ffd-8f13-3050-5248-581676b7ea42	Product name	6	20221214
987af351-b977-4822-ac44-c76d29e24e78	Product name	1	20190611

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0254-2008-01	2025-01-30	C162847	48780-1	2cef2736-63c1-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for Colchicine Tablets, USP. Colchicine Tablets, USP, for oral use Initial U.S. Approval: 1961
0254-2008-11	2025-01-30	C162847	48780-1	2cef2736-63c1-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for Colchicine Tablets, USP. Colchicine Tablets, USP, for oral use Initial U.S. Approval: 1961

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0254-2008-01	Colchicine	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100		3
0254-2008-11	Colchicine	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0254-2008-01	EA - Each	0254-2008	77906ac2-97d0-4066-94d1-f168d0568681	1	2018-07-03
0254-2008-11	EA - Each	0254-2008	cd281ad2-bec4-426d-8980-d3cc7687ad42	1	2018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0254-2008	COLCHICINE TABLET, FILM COATED [PAR PHARMACEUTICAL, INC.]	3	Legacy NDC, 2 package rows	20211202_fc439ae8-a79e-4942-8d02-22422b19b015.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COLCHICINE	COLCHICINE	direct rx	c7d013b7-0a67-0953-e053-2a95a90ac47c	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022352 application number: NDA022352
Colchicine	COLCHICINE	Bryant Ranch Prepack	a15538ee-d1eb-4118-97c3-53748cea012a	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022352 application number: NDA022352
Colchicine	COLCHICINE	Bryant Ranch Prepack	df1dd89a-a1b3-48e8-b0e8-ad71b4cb0c96	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022352 application number: NDA022352
Colchicine	COLCHICINE	Bryant Ranch Prepack	5e5d9488-d9d0-4b37-b535-941d66c3430d	2024-01-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022352 application number: NDA022352
Colcrys	COLCHICINE	Proficient Rx LP	d6adc880-5499-4691-93f3-27c87902d5fc	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022352 application number: NDA022352

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SML2Y3J35T	COLCHICINE	64-86-8	COLCHICINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197541	colchicine 0.6 MG Oral Tablet	PSN	a15538ee-d1eb-4118-97c3-53748cea012a	104
197541	colchicine 0.6 MG Oral Tablet	SCD	a15538ee-d1eb-4118-97c3-53748cea012a	104
197541	colchicine 600 MCG Oral Tablet	SY	a15538ee-d1eb-4118-97c3-53748cea012a	104
197541	colchicine 0.6 MG Oral Tablet	PSN	5e5d9488-d9d0-4b37-b535-941d66c3430d	103
197541	colchicine 0.6 MG Oral Tablet	PSN	df1dd89a-a1b3-48e8-b0e8-ad71b4cb0c96	103
197541	colchicine 0.6 MG Oral Tablet	SCD	5e5d9488-d9d0-4b37-b535-941d66c3430d	103
197541	colchicine 0.6 MG Oral Tablet	SCD	df1dd89a-a1b3-48e8-b0e8-ad71b4cb0c96	103
197541	colchicine 600 MCG Oral Tablet	SY	5e5d9488-d9d0-4b37-b535-941d66c3430d	103
197541	colchicine 600 MCG Oral Tablet	SY	df1dd89a-a1b3-48e8-b0e8-ad71b4cb0c96	103
197541	colchicine 0.6 MG Oral Tablet	PSN	96ca32da-68cc-d757-e053-2995a90a76d8	7
197541	colchicine 0.6 MG Oral Tablet	SCD	96ca32da-68cc-d757-e053-2995a90a76d8	7
197541	colchicine 600 MCG Oral Tablet	SY	96ca32da-68cc-d757-e053-2995a90a76d8	7
197541	colchicine 0.6 MG Oral Tablet	PSN	fc439ae8-a79e-4942-8d02-22422b19b015	3
197541	colchicine 0.6 MG Oral Tablet	SCD	fc439ae8-a79e-4942-8d02-22422b19b015	3
197541	colchicine 600 MCG Oral Tablet	SY	fc439ae8-a79e-4942-8d02-22422b19b015	3
197541	colchicine 0.6 MG Oral Tablet	PSN	c7d013b7-0a67-0953-e053-2a95a90ac47c	2
197541	colchicine 0.6 MG Oral Tablet	SCD	c7d013b7-0a67-0953-e053-2a95a90ac47c	2
197541	colchicine 600 MCG Oral Tablet	SY	c7d013b7-0a67-0953-e053-2a95a90ac47c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0254-2008-01	00254200801	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0254-2008-01)	2018-07-01	0000-00-00	No	No	Current
0254-2008-11	00254200811	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0254-2008-11)	2018-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
COLCHICINE	direct rx	2025-01-20	HUMAN PRESCRIPTION DRUG LABEL	2
Colchicine 0.6mg	RedPharm Drug, Inc.	2024-08-02	HUMAN PRESCRIPTION DRUG LABEL	7
Colchicine	Bryant Ranch Prepack	2024-05-22	HUMAN PRESCRIPTION DRUG LABEL	104
Colchicine	Bryant Ranch Prepack	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	103
Colchicine	Bryant Ranch Prepack	2024-01-10	HUMAN PRESCRIPTION DRUG LABEL	103
Colchicine	American Health Packaging	2023-06-09	HUMAN PRESCRIPTION DRUG LABEL	6
Colchicine	Proficient Rx LP	2022-11-01	HUMAN PRESCRIPTION DRUG LABEL	3
Colchicine	Par Pharmaceutical, Inc.	2021-11-20	HUMAN PRESCRIPTION DRUG LABEL	3