Colchicine

Product NDC: 72189-687
11-digit product format: 721890687
Labeler code: 72189
Product ID: 72189-687_5a0b4246-e7de-29e5-e063-6294a90a2871
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Colchicine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Direct_Rx
Application: ANDA208993
Marketing category: ANDA
Marketing start: 2026-08-27
Substance: COLCHICINE
Active strength: .6 mg/1
Pharmacologic classes: Alkaloid [EPC], Alkaloids [CS]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A208993-001	COLCHICINE	COLCHICINE	0.6MG	TABLET / ORAL	AB		2021-08-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208993-001	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
2026-09-14 22:38:34	2026-08	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208993-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2021-08-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208993-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208993-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208993-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208993-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208993-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208993-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208993-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208993-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208993-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208993-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208993-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208993-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208993-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208993-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208993-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208993-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208993-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208993-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208993-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208993-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208993-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208993-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208993-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208993-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208993-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208993-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208993-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208993-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208993-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208993-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208993-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208993-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208993-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208993-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208993-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Colchicine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
COLCHICINE	.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SML2Y3J35T	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197541	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5a0b4246-e7dd-29e5-e063-6294a90a2871	Available on FDA.report

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colchicine	COLCHICINE	Direct_Rx	5a0b4246-e7dd-29e5-e063-6294a90a2871	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208993 application number: ANDA208993 ndc (product): 72189-687
Colchicine	COLCHICINE	PD-Rx Pharmaceuticals, Inc.	68d4bf2b-8e2c-4621-aa08-463f43e253c3	2026-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208993 application number: ANDA208993
Colchicine	COLCHICINE	Bryant Ranch Prepack	5cefec2e-1982-4417-8d99-5711231b3933	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208993 application number: ANDA208993
Colchicine	COLCHICINE	Camber Pharmaceuticals, Inc.	1e7ef16d-262b-4dc0-92d6-7afe4aa21ebd	2021-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208993 application number: ANDA208993

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	Sample	Exclude flag	Status
72189-687-03	72189068703	3 TABLET, FILM COATED in 1 BOTTLE (72189-687-03)	2026-08-27	No	No	Current