Colcrys

Product NDC: 13310-119
11-digit product format: 133100119
Labeler code: 13310
Product ID: 13310-119_d6eb54b7-2050-4449-85b8-1592cec62176
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Colchicine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: AR Scientific Inc.
Application: NDA022352
Marketing category: NDA
Marketing start: 2009-09-01
Marketing end: 0000-00-00
Substance: COLCHICINE
Active strength: 1 mg/1
Pharmacologic classes: Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	13310-119		I	Inactivated by FDA	2026-08-11
excluded package	package	13310-119	13310-119-01	I	Inactivated by FDA	2026-08-11
excluded package	package	13310-119	13310-119-03	I	Inactivated by FDA	2026-08-11
excluded package	package	13310-119	13310-119-05	I	Inactivated by FDA	2026-08-11
excluded package	package	13310-119	13310-119-06	I	Inactivated by FDA	2026-08-11
excluded package	package	13310-119	13310-119-07	I	Inactivated by FDA	2026-08-11
excluded package	package	13310-119	13310-119-10	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 3 · 154 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13310-119-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13310-119-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13310-119-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13310-119-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13310-119-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	13310-119-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13310-119-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13310-119-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13310-119-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13310-119-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13310-119-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	13310-119-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13310-119-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13310-119-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13310-119-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13310-119-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13310-119-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	13310-119-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13310-119-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13310-119-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13310-119-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13310-119-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13310-119-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	13310-119-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13310-119-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13310-119-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13310-119-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13310-119-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13310-119-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	13310-119-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13310-119-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13310-119-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13310-119-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13310-119-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13310-119-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	13310-119-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13310-119-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13310-119-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13310-119-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13310-119-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13310-119-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	13310-119-01	`302b2466d912…`	`e7b80fea0513…`
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	13310-119-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13310-119-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13310-119-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13310-119-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13310-119-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	13310-119-01	`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	13310-119-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13310-119-07	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	13310-119-06	`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, Related label table
NDC	Related label
13310-119-01	These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for COLCRYS ® . COLCRYS ® (colchicine, USP) tablets for Oral use Initial U.S. Approval: 1961
13310-119-03	These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for COLCRYS ® . COLCRYS ® (colchicine, USP) tablets for Oral use Initial U.S. Approval: 1961
13310-119-05	These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for COLCRYS ® . COLCRYS ® (colchicine, USP) tablets for Oral use Initial U.S. Approval: 1961
13310-119-06	These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for COLCRYS ® . COLCRYS ® (colchicine, USP) tablets for Oral use Initial U.S. Approval: 1961
13310-119-07	These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for COLCRYS ® . COLCRYS ® (colchicine, USP) tablets for Oral use Initial U.S. Approval: 1961
13310-119-10	These highlights do not include all the information needed to use colchicine safely and effectively. See full prescribing information for COLCRYS ® . COLCRYS ® (colchicine, USP) tablets for Oral use Initial U.S. Approval: 1961

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
13310-119-01	Colcrys	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	14
13310-119-03	Colcrys	250 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	250	14
13310-119-05	Colcrys	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	14
13310-119-06	Colcrys	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	14
13310-119-07	Colcrys	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	14
13310-119-10	Colcrys	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1000	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13310-119-01	EA - Each	13310-119	958894f5-b1df-4d90-b456-89d8ea5c83f1	1	2012-07-24
13310-119-07	EA - Each	13310-119	665b9f02-4226-4ee4-b2fd-5352a76a245a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Colchicine	ACTIVE INGREDIENT	SML2Y3J35T	COLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]	14
Colchicine	ACTIVE MOIETY	SML2Y3J35T	COLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]	14
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	COLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]	14
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	COLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]	14
FD&C blue no. 2	INACTIVE INGREDIENT	L06K8R7DQK	COLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]	14
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	COLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]	14
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	COLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]	14
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	COLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]	14
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	COLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]	14
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	COLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]	14
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	COLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]	14
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	COLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]	14
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	COLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]	14
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	COLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]	14
triacetin	INACTIVE INGREDIENT	XHX3C3X673	COLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]	14
Colchicine	ACTIVE INGREDIENT	SML2Y3J35T	COLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
Colchicine	ACTIVE MOIETY	SML2Y3J35T	COLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	COLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	COLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
FD&C blue no. 2	INACTIVE INGREDIENT	L06K8R7DQK	COLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	COLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	COLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	COLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	COLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	COLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	COLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	COLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	COLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	COLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2
triacetin	INACTIVE INGREDIENT	XHX3C3X673	COLCRYS (COLCHICINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13310-119	COLCRYS (COLCHICINE) TABLET, FILM COATED [AR SCIENTIFIC INC.]	14	Legacy NDC, 6 package rows	20120604_5ecaa34e-1bed-49a5-b97c-a8f8c0d885a7.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	5ecaa34e-1bed-49a5-b97c-a8f8c0d885a7	14
858071	Colcrys 0.6 MG Oral Tablet	PSN	5ecaa34e-1bed-49a5-b97c-a8f8c0d885a7	14
858071	colchicine 0.6 MG Oral Tablet [Colcrys]	SBD	5ecaa34e-1bed-49a5-b97c-a8f8c0d885a7	14
197541	colchicine 0.6 MG Oral Tablet	SCD	5ecaa34e-1bed-49a5-b97c-a8f8c0d885a7	14
197541	colchicine 600 MCG Oral Tablet	SY	5ecaa34e-1bed-49a5-b97c-a8f8c0d885a7	14
858071	Colcrys (colchicine 0.6 MG) Oral Tablet	SY	5ecaa34e-1bed-49a5-b97c-a8f8c0d885a7	14
858071	Colcrys 0.6 MG Oral Tablet	SY	5ecaa34e-1bed-49a5-b97c-a8f8c0d885a7	14
197541	colchicine 0.6 MG Oral Tablet	PSN	4e936802-5b5d-4772-8b1d-4f30867ffa59	2
858071	Colcrys 0.6 MG Oral Tablet	PSN	4e936802-5b5d-4772-8b1d-4f30867ffa59	2
858071	colchicine 0.6 MG Oral Tablet [Colcrys]	SBD	4e936802-5b5d-4772-8b1d-4f30867ffa59	2
197541	colchicine 0.6 MG Oral Tablet	SCD	4e936802-5b5d-4772-8b1d-4f30867ffa59	2
197541	colchicine 600 MCG Oral Tablet	SY	4e936802-5b5d-4772-8b1d-4f30867ffa59	2
858071	Colcrys (colchicine 0.6 MG) Oral Tablet	SY	4e936802-5b5d-4772-8b1d-4f30867ffa59	2
858071	Colcrys 0.6 MG Oral Tablet	SY	4e936802-5b5d-4772-8b1d-4f30867ffa59	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
13310-119-01	13310011901	100 in 1 BOTTLE, PLASTIC	Historical
13310-119-03	13310011903	250 in 1 BOTTLE, PLASTIC	Historical
13310-119-05	13310011905	500 in 1 BOTTLE, PLASTIC	Historical
13310-119-06	13310011906	60 in 1 BOTTLE, PLASTIC	Historical
13310-119-07	13310011907	30 in 1 BOTTLE, PLASTIC	Historical
13310-119-10	13310011910	1000 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colcrys	Physicians Total Care, Inc.	2012-04-24	HUMAN PRESCRIPTION DRUG LABEL	2
Colcrys	AR Scientific Inc.	2012-03-15	HUMAN PRESCRIPTION DRUG LABEL	14