colchicine

Product NDC: 68071-2567
11-digit product format: 680712567
Labeler code: 68071
Product ID: 68071-2567_2b615ac9-9f1b-59ee-e063-6294a90a30d2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: colchicine
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA211250
Marketing category: ANDA
Marketing start: 2019-02-10
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

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2567-9	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68071-2567-9	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68071-2567-9	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68071-2567-9	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-2567-9	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-2567-9	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-2567-9	`1332a3947898…`	`d4bfe170f9cd…`

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
A211250-001	COLCHICINE	COLCHICINE	0.6MG	TABLET / ORAL	AB		2019-02-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211250-001	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.

Product history page 1 of 2 · 41 observed 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	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211250-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-08	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A211250-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211250-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211250-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211250-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211250-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211250-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211250-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211250-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211250-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211250-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211250-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211250-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211250-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211250-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211250-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211250-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211250-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211250-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211250-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211250-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211250-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211250-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211250-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211250-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211250-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211250-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211250-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211250-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211250-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211250-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211250-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211250-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211250-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211250-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211250-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211250-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211250-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211250-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211250-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211250-001	AB	1	`cb3db0bc1861…`

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
d010a735-1a20-23fe-e053-2995a90abe0f	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2567-9	2025-01-10	C162847	48780-1	f386c64a-2fa3-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use COLCHICINE TABLETS safely and effectively. See full prescribing information for COLCHICINE TABLETS. COLCHICINE tablets, for oral use Initial U.S. Approval: 1961
68071-2567-9	2023-01-30	C162847	48780-1	f386c64a-2fa3-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use COLCHICINE TABLETS safely and effectively. See full prescribing information for COLCHICINE TABLETS. COLCHICINE tablets, for oral use Initial U.S. Approval: 1961

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2567-9	colchicine	90 in 1 BOTTLE	TABLET	90		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2567	COLCHICINE TABLET [NUCARE PHARMACEUTICALS,INC.]	2	Current NDC, Legacy NDC, 1 package rows	20250112_d010a735-1a20-23fe-e053-2995a90abe0f.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
colchicine	COLCHICINE	A-S Medication Solutions	5c1ceff7-8f00-48cc-8ea4-678106455ff1	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211250 application number: ANDA211250
colchicine	COLCHICINE	Bryant Ranch Prepack	5ae87893-a065-468e-b8da-f1db86afcaef	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211250 application number: ANDA211250
colchicine	COLCHICINE	Ascend Laboratories, LLC	a4284783-fea6-4af2-9a8d-79c929176c05	2026-06-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211250 application number: ANDA211250
colchicine	COLCHICINE	ST. MARY'S MEDICAL PARK PHARMACY	5102af58-15b1-1516-e063-6294a90a50e3	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211250 application number: ANDA211250
colchicine	COLCHICINE	Bryant Ranch Prepack	8b78d6f7-714b-4e6c-b109-fbcb96d66633	2025-11-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211250 application number: ANDA211250
colchicine	COLCHICINE	NuCare Pharmaceuticals,Inc.	d010a735-1a20-23fe-e053-2995a90abe0f	2025-01-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211250 application number: ANDA211250 ndc (product): 68071-2567
colchicine	COLCHICINE	Bryant Ranch Prepack	11a62c34-db88-4a79-81a1-59b316d41d66	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211250 application number: ANDA211250

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	d010a735-1a20-23fe-e053-2995a90abe0f	2
197541	colchicine 0.6 MG Oral Tablet	SCD	d010a735-1a20-23fe-e053-2995a90abe0f	2
197541	colchicine 600 MCG Oral Tablet	SY	d010a735-1a20-23fe-e053-2995a90abe0f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2567-9	68071256709	90 TABLET in 1 BOTTLE (68071-2567-9)	90 tablet	2021-11-05	0000-00-00	No	No	Current