colchicine

Product NDC: 67877-589
11-digit product format: 678770589
Labeler code: 67877
Product ID: 67877-589_498d5cac-62d7-4f25-b974-52b732abd789
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: colchicine
Dosage form: TABLET
Route: ORAL
Labeler: Ascend Laboratories, LLC
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

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: 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
a4284783-fea6-4af2-9a8d-79c929176c05	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	SPL version
67877-589-01	colchicine	100 in 1 BOTTLE	TABLET	100	9
67877-589-05	colchicine	500 in 1 BOTTLE	TABLET	500	9
67877-589-10	colchicine	1000 in 1 BOTTLE	TABLET	1000	9
67877-589-30	colchicine	30 in 1 BOTTLE	TABLET	30	9
67877-589-33	colchicine	10 in 1 BLISTER PACK	TABLET	10	9
67877-589-33	colchicine	1 in 1 CARTON	TABLET	1	9
67877-589-60	colchicine	60 in 1 BOTTLE	TABLET	60	9
67877-589-84	colchicine	10 in 1 BLISTER PACK	TABLET	10	9
67877-589-84	colchicine	3 in 1 CARTON	TABLET	3	9
67877-589-86	colchicine	250 in 1 BOTTLE	TABLET	250	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67877-589-01	EA - Each	67877-589	f651ca1b-3bf2-42e8-93eb-eab222aecd06	1	2020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67877-589	COLCHICINE TABLET [ASCEND LABORATORIES, LLC]	7	Current NDC, Legacy NDC, 10 package rows	20220727_a4284783-fea6-4af2-9a8d-79c929176c05.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 ndc (product): 67877-589
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
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	11a62c34-db88-4a79-81a1-59b316d41d66	107
197541	colchicine 0.6 MG Oral Tablet	SCD	11a62c34-db88-4a79-81a1-59b316d41d66	107
197541	colchicine 600 MCG Oral Tablet	SY	11a62c34-db88-4a79-81a1-59b316d41d66	107
197541	colchicine 0.6 MG Oral Tablet	PSN	5ae87893-a065-468e-b8da-f1db86afcaef	106
197541	colchicine 0.6 MG Oral Tablet	SCD	5ae87893-a065-468e-b8da-f1db86afcaef	106
197541	colchicine 600 MCG Oral Tablet	SY	5ae87893-a065-468e-b8da-f1db86afcaef	106
197541	colchicine 0.6 MG Oral Tablet	PSN	8b78d6f7-714b-4e6c-b109-fbcb96d66633	102
197541	colchicine 0.6 MG Oral Tablet	SCD	8b78d6f7-714b-4e6c-b109-fbcb96d66633	102
197541	colchicine 600 MCG Oral Tablet	SY	8b78d6f7-714b-4e6c-b109-fbcb96d66633	102
197541	colchicine 0.6 MG Oral Tablet	PSN	a4284783-fea6-4af2-9a8d-79c929176c05	9
197541	colchicine 0.6 MG Oral Tablet	SCD	a4284783-fea6-4af2-9a8d-79c929176c05	9
197541	colchicine 600 MCG Oral Tablet	SY	a4284783-fea6-4af2-9a8d-79c929176c05	9
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
197541	colchicine 0.6 MG Oral Tablet	PSN	5102af58-15b1-1516-e063-6294a90a50e3	1
197541	colchicine 0.6 MG Oral Tablet	SCD	5102af58-15b1-1516-e063-6294a90a50e3	1
197541	colchicine 600 MCG Oral Tablet	SY	5102af58-15b1-1516-e063-6294a90a50e3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67877-589-01	67877058901	100 TABLET in 1 BOTTLE (67877-589-01)	100 tablet	2019-02-10	0000-00-00	No	No	Current
67877-589-05	67877058905	500 TABLET in 1 BOTTLE (67877-589-05)	500 tablet	2019-02-10	0000-00-00	No	No	Current
67877-589-10	67877058910	1000 TABLET in 1 BOTTLE (67877-589-10)	1000 tablet	2019-02-10	0000-00-00	No	No	Current
67877-589-30	67877058930	30 TABLET in 1 BOTTLE (67877-589-30)	30 tablet	2019-02-10	0000-00-00	No	No	Current
67877-589-33	67877058933	1 BLISTER PACK in 1 CARTON (67877-589-33) / 10 TABLET in 1 BLISTER PACK	1 blister pack	2019-02-10	0000-00-00	No	No	Current
67877-589-60	67877058960	60 TABLET in 1 BOTTLE (67877-589-60)	60 tablet	2019-02-10	0000-00-00	No	No	Current
67877-589-84	67877058984	3 BLISTER PACK in 1 CARTON (67877-589-84) / 10 TABLET in 1 BLISTER PACK	3 blister pack	2019-02-10	0000-00-00	No	No	Current
67877-589-86	67877058986	250 TABLET in 1 BOTTLE (67877-589-86)	250 tablet	2019-02-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
colchicine	A-S Medication Solutions	2026-07-15	Human Prescription Drug Label	1
colchicine	Bryant Ranch Prepack	2026-07-14	HUMAN PRESCRIPTION DRUG LABEL	107
colchicine	Ascend Laboratories, LLC \| Alkem Laboratories Limited	2026-06-23	Human Prescription Drug Label	10
colchicine	ST. MARY'S MEDICAL PARK PHARMACY	2026-05-04	HUMAN PRESCRIPTION DRUG LABEL	1
colchicine	Bryant Ranch Prepack	2025-11-03	HUMAN PRESCRIPTION DRUG LABEL	102
colchicine	NuCare Pharmaceuticals,Inc.	2025-01-10	HUMAN PRESCRIPTION DRUG LABEL	2
colchicine	Bryant Ranch Prepack	2024-08-14	HUMAN PRESCRIPTION DRUG LABEL	107
colchicine	Bryant Ranch Prepack	2022-09-19	HUMAN PRESCRIPTION DRUG LABEL	7