Colcrys

Product NDC: 64764-119
Requested package NDC: 64764-119-06
11-digit product format: 647640119
Labeler code: 64764
Product ID: 64764-119_93732d0e-7f4c-45d0-a522-76962b79434f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Colchicine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Takeda Pharmaceuticals America, 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: Alkaloid [EPC], Alkaloids [CS], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Interactions [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	64764-119	64764-119-06	D	Discontinued by firm		2026-08-11

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N022352-001	COLCRYS	COLCHICINE	0.6MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-07-29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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64764-119-01	EA - Each	64764-119	52719dce-a115-4b80-bc47-74390c474842	1	2013-02-13
64764-119-07	EA - Each	64764-119	904dcc80-dd95-41f9-b226-965b46d41a86	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Colchicine	ACTIVE INGREDIENT	SML2Y3J35T	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
Colchicine	ACTIVE MOIETY	SML2Y3J35T	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
FD&C blue no. 2	INACTIVE INGREDIENT	L06K8R7DQK	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
triacetin	INACTIVE INGREDIENT	XHX3C3X673	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	5
Colchicine	ACTIVE INGREDIENT	SML2Y3J35T	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
Colchicine	ACTIVE INGREDIENT	SML2Y3J35T	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
Colchicine	ACTIVE MOIETY	SML2Y3J35T	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
Colchicine	ACTIVE MOIETY	SML2Y3J35T	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
carnauba wax	INACTIVE INGREDIENT	R12CBM0EIZ	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FD&C blue no. 2	INACTIVE INGREDIENT	L06K8R7DQK	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
FD&C blue no. 2	INACTIVE INGREDIENT	L06K8R7DQK	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
FD&C red no. 40	INACTIVE INGREDIENT	WZB9127XOA	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
polydextrose	INACTIVE INGREDIENT	VH2XOU12IE	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
polyethylene glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1
triacetin	INACTIVE INGREDIENT	XHX3C3X673	COLCRYS (COLCHICINE) TABLET, FILM COATED [PROFICIENT RX LP]	1
triacetin	INACTIVE INGREDIENT	XHX3C3X673	COLCRYS (COLCHICINE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64764-119	COLCRYS (COLCHICINE) TABLET, FILM COATED [TAKEDA PHARMACEUTICALS AMERICA, INC.]	14	Legacy NDC	20231230_56c130d1-7581-4152-99a2-0014ee9366c0.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	d6adc880-5499-4691-93f3-27c87902d5fc	4
858071	Colcrys 0.6 MG Oral Tablet	PSN	d6adc880-5499-4691-93f3-27c87902d5fc	4
858071	colchicine 0.6 MG Oral Tablet [Colcrys]	SBD	d6adc880-5499-4691-93f3-27c87902d5fc	4
197541	colchicine 0.6 MG Oral Tablet	SCD	d6adc880-5499-4691-93f3-27c87902d5fc	4
197541	colchicine 600 MCG Oral Tablet	SY	d6adc880-5499-4691-93f3-27c87902d5fc	4
858071	Colcrys (colchicine 0.6 MG) Oral Tablet	SY	d6adc880-5499-4691-93f3-27c87902d5fc	4
858071	Colcrys 0.6 MG Oral Tablet	SY	d6adc880-5499-4691-93f3-27c87902d5fc	4
197541	colchicine 0.6 MG Oral Tablet	PSN	a80036fe-3016-4541-aa42-6c06cf37ae55	2
858071	Colcrys 0.6 MG Oral Tablet	PSN	a80036fe-3016-4541-aa42-6c06cf37ae55	2
858071	colchicine 0.6 MG Oral Tablet [Colcrys]	SBD	a80036fe-3016-4541-aa42-6c06cf37ae55	2
197541	colchicine 0.6 MG Oral Tablet	SCD	a80036fe-3016-4541-aa42-6c06cf37ae55	2
197541	colchicine 600 MCG Oral Tablet	SY	a80036fe-3016-4541-aa42-6c06cf37ae55	2
858071	Colcrys (colchicine 0.6 MG) Oral Tablet	SY	a80036fe-3016-4541-aa42-6c06cf37ae55	2
858071	Colcrys 0.6 MG Oral Tablet	SY	a80036fe-3016-4541-aa42-6c06cf37ae55	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
64764-119-06	64764011906	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64764-119-06)	2009-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colcrys	Takeda Pharmaceuticals America, Inc.	2025-07-23	HUMAN PRESCRIPTION DRUG LABEL	15
Colcrys	Proficient Rx LP	2022-10-01	HUMAN PRESCRIPTION DRUG LABEL	4
Colcrys	Aphena Pharma Solutions - Tennessee, LLC	2019-12-19	HUMAN PRESCRIPTION DRUG LABEL	2