Colchicine

Product NDC: 0378-1086
11-digit product format: 003781086
Labeler code: 0378
Product ID: 0378-1086_9ba74921-d6b7-40a8-aa1e-d7431574a137
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Colchicine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA209470
Marketing category: ANDA
Marketing start: 2019-11-25
Substance: COLCHICINE
Active strength: .6 mg/1
Pharmacologic classes: Alkaloid [EPC], Alkaloids [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0378-1086	0378-1086-93	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A209470-001	COLCHICINE	COLCHICINE	0.6MG	TABLET / ORAL	AB		2019-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209470-001	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	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL		2019-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL		2019-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL		2019-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL		2019-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL		2019-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL		2019-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL		2019-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL		2019-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209470-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-16	`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	A209470-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209470-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209470-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209470-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209470-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209470-001	AB	1	`03ed91905a0d…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209470-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209470-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209470-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209470-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209470-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209470-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209470-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209470-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209470-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209470-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209470-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209470-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209470-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209470-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209470-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209470-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209470-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209470-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209470-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209470-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209470-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209470-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209470-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209470-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209470-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Colchicine
Listing expiration: 2026-12-31

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
85acf34c-06c6-40ea-95f4-060d5de99277	Available on FDA.report

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
0378-1086-01	Colchicine	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100		6
0378-1086-93	Colchicine	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-1086-01	EA - Each	0378-1086	c52105fd-d6ce-465c-8b8d-7c120152a848	1	2019-12-10
0378-1086-93	EA - Each	0378-1086	514b983a-3a94-458f-b4de-84199d993e05	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-1086	COLCHICINE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]	6	Current NDC, Legacy NDC, 2 package rows	20240618_85acf34c-06c6-40ea-95f4-060d5de99277.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	Mylan Pharmaceuticals Inc.	85acf34c-06c6-40ea-95f4-060d5de99277	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209470 application number: ANDA209470 ndc (product): 0378-1086

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	85acf34c-06c6-40ea-95f4-060d5de99277	6
197541	colchicine 0.6 MG Oral Tablet	SCD	85acf34c-06c6-40ea-95f4-060d5de99277	6
197541	colchicine 600 MCG Oral Tablet	SY	85acf34c-06c6-40ea-95f4-060d5de99277	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0378-1086-01	00378108601	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1086-01)	2019-11-25	0000-00-00	No	No	Current
0378-1086-93	00378108693	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1086-93)	2019-11-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colchicine	Mylan Institutional Inc.	2023-01-06	HUMAN PRESCRIPTION DRUG LABEL	11
Colchicine	Mylan Pharmaceuticals Inc.	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	6