Colchicine

Product NDC: 0591-2562
11-digit product format: 005912562
Labeler code: 0591
Product ID: 0591-2562_1a2cbb1f-af4c-4f84-83aa-3e59d5859758
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Colchicine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA204461
Marketing category: ANDA
Marketing start: 2020-12-02
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0591-2562		D	Discontinued by firm	2026-08-11
excluded package	package	0591-2562	0591-2562-01	D	Discontinued by firm	2026-08-11
excluded package	package	0591-2562	0591-2562-30	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
A204461-001	COLCHICINE	COLCHICINE	0.6MG	TABLET / ORAL	AB		2019-07-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A204461-001	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204461-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-07-31	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204461-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204461-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204461-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204461-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204461-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204461-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204461-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204461-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204461-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204461-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204461-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204461-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204461-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204461-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204461-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204461-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204461-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204461-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204461-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204461-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204461-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204461-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204461-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204461-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204461-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204461-001	AB	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204461-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204461-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204461-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204461-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204461-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204461-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204461-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204461-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204461-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204461-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204461-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204461-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204461-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204461-001	AB	1	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-2562-01	EA - Each	0591-2562	4418f6ab-4606-4725-a0bd-bd5e54ef4aea	1	2021-01-08
0591-2562-30	EA - Each	0591-2562	ad7bc5bb-c3b3-4fa3-b297-83e7481cc64d	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-2562	COLCHICINE TABLET, FILM COATED [ACTAVIS PHARMA, INC.]	6	Legacy NDC	20250226_9e5b59cb-1749-4999-83d0-b82097515e4b.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-2562-01	00591256201	100 TABLET, FILM COATED in 1 BOTTLE (0591-2562-01)	2020-12-02	0000-00-00	No	No	Current
0591-2562-30	00591256230	30 TABLET, FILM COATED in 1 BOTTLE (0591-2562-30)	2020-12-02	0000-00-00	No	No	Current