Colchicine

Product NDC: 23155-855
11-digit product format: 231550855
Labeler code: 23155
Product ID: 23155-855_9031a018-6f13-4302-ab8b-084b672f5f94
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Colchicine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application: ANDA209173
Marketing category: ANDA
Marketing start: 2023-03-26
Marketing end: 2026-07-31
Substance: COLCHICINE
Active strength: .6 mg/1
Pharmacologic classes: Alkaloid [EPC], Alkaloids [CS]
NDC exclude flag: No
Current FDA listing: Yes

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	23155-855		D	Discontinued by firm	2026-08-11
excluded package	package	23155-855	23155-855-01	D	Discontinued by firm	2026-08-11
excluded package	package	23155-855	23155-855-03	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
A209173-001	COLCHICINE	COLCHICINE	0.6MG	TABLET / ORAL	AB		2022-03-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209173-001	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	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`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	A209173-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209173-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209173-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209173-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209173-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209173-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209173-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209173-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209173-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209173-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209173-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209173-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209173-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209173-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209173-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209173-001	AB	1	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209173-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209173-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209173-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209173-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209173-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209173-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209173-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209173-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209173-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209173-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209173-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209173-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209173-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209173-001	AB	1	`a50c72e98297…`

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
23155-855-01	Colchicine	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100		3
23155-855-03	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
23155-855-01	EA - Each	23155-855	171846f5-adab-47f5-8798-5b65f7f8e4cc	1	2023-07-06
23155-855-03	EA - Each	23155-855	9c054304-a018-46b2-8741-758e5a8e3ac6	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
23155-855	COLCHICINE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]	1	Current NDC, 2 package rows	20230326_28efb8cf-3ef4-4cd6-b6f6-131f3ca01112.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colchicine	COLCHICINE	Chartwell RX, LLC	16d8e0f4-567d-4de1-ac25-6e2527f1d58e	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209173 application number: ANDA209173
Colchicine	COLCHICINE	Strides Pharma Science Limited	50b9c910-49a3-4a57-80f5-dc36c09da4df	2025-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209173 application number: ANDA209173

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	28efb8cf-3ef4-4cd6-b6f6-131f3ca01112	3
197541	colchicine 0.6 MG Oral Tablet	SCD	28efb8cf-3ef4-4cd6-b6f6-131f3ca01112	3
197541	colchicine 600 MCG Oral Tablet	SY	28efb8cf-3ef4-4cd6-b6f6-131f3ca01112	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
23155-855-01	23155085501	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (23155-855-01)	2023-03-26	2026-07-31	No	No	Historical
23155-855-03	23155085503	30 in 1 BOTTLE, PLASTIC					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colchicine	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. \| Strides Pharma Science Limited	2025-12-25	HUMAN PRESCRIPTION DRUG LABEL	3