Colchicine

Product NDC: 64380-796
11-digit product format: 643800796
Labeler code: 64380
Product ID: 64380-796_8de9440c-7d34-4837-8bdf-b31d84dff43a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Colchicine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Strides Pharma Science Limited
Application: ANDA209173
Marketing category: ANDA
Marketing start: 2022-09-19
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

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	64380-796		D	Discontinued by firm	2026-09-14
excluded package	package	64380-796	64380-796-04	D	Discontinued by firm	2026-09-14
excluded package	package	64380-796	64380-796-06	D	Discontinued by firm	2026-09-14

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
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
2026-09-14 22:38:34	2026-08	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209173-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-03-10	`caaa826d4ba7…`
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
2026-09-14 22:38:34	2026-08	A209173-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209173-001	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

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
64380-796-04	Colchicine	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		9
64380-796-06	Colchicine	100 in 1 BOTTLE	TABLET, FILM COATED	100		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
64380-796-04	EA - Each	64380-796	2aa2558e-5f0c-4731-870b-c725680e4aa2	1	2022-10-06
64380-796-06	EA - Each	64380-796	addb1713-d58c-4fb8-9bf7-666aa05144b5	1	2022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64380-796	COLCHICINE TABLET, FILM COATED [STRIDES PHARMA SCIENCE LIMITED]	8	Current NDC, Legacy NDC, 2 package rows	20230219_50b9c910-49a3-4a57-80f5-dc36c09da4df.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 · 1 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

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
64380-796-04	64380079604	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (64380-796-04)	2022-09-19	0000-00-00	No	No	Current
64380-796-06	64380079606	100 TABLET, FILM COATED in 1 BOTTLE (64380-796-06)	2022-09-19	0000-00-00	No	No	Current