Colchicine

Product NDC: 16714-039
11-digit product format: 167140039
Labeler code: 16714
Product ID: 16714-039_b510d002-4c8e-4b5e-bc76-c49552e79d45
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Colchicine
Dosage form: TABLET
Route: ORAL
Labeler: Northstar Rx LLC.
Application: ANDA211519
Marketing category: ANDA
Marketing start: 2020-11-10
Substance: COLCHICEINE
Active strength: .6 mg/1
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211519-001	COLCHICINE	COLCHICINE	0.6MG	TABLET / ORAL	AB		2019-02-19
A211519-002	COLCHICINE	COLCHICINE	0.3MG	TABLET / ORAL			2019-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211519-001	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 · 78 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	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL		2019-02-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211519-002	COLCHICINE	0.3MG	TABLET / ORAL		2019-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211519-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-02-19	`87673890dc5c…`

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	A211519-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211519-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211519-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211519-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211519-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211519-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211519-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211519-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211519-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211519-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211519-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211519-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211519-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211519-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211519-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211519-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211519-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211519-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211519-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211519-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211519-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211519-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211519-001	AB	1	`c0c555d07b60…`
2019-07-19 19:46 UTC	2019-07	A211519-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211519-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211519-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211519-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211519-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211519-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211519-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211519-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211519-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211519-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211519-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211519-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211519-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211519-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211519-001	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
COLCHICEINE	.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
HJ30158L57	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
94bee24f-d846-4344-bc42-b2eae6b433ba	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
16714-039-01	Colchicine	1 in 1 CARTON	TABLET	1	2
16714-039-01	Colchicine	30 in 1 BOTTLE	TABLET	30	2
16714-039-02	Colchicine	1 in 1 CARTON	TABLET	1	2
16714-039-02	Colchicine	100 in 1 BOTTLE	TABLET	100	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16714-039	COLCHICINE TABLET [NORTHSTAR RX LLC.]	2	Current NDC, Legacy NDC, 4 package rows	20221211_94bee24f-d846-4344-bc42-b2eae6b433ba.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colchicine	COLCHICINE	Zydus Lifesciences Limited	cd720ef0-1cb8-40bc-a657-10accb6542b6	2024-11-26		Exact identifier application applno (ANDA): 211519 application number: ANDA211519
Colchicine	COLCHICINE	A-S Medication Solutions	7b6abc78-b2d6-4949-b109-4c857f37ef12	2024-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211519 application number: ANDA211519
Colchicine	COLCHICINE	Northstar Rx LLC.	94bee24f-d846-4344-bc42-b2eae6b433ba	2022-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211519 application number: ANDA211519 ndc (product): 16714-039
Colchicine	COLCHICINE	Zydus Pharmaceuticals USA Inc.	c8fd7034-5ca2-4a58-b303-7f78ffdf8d76	2022-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211519 application number: ANDA211519

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HJ30158L57	COLCHICEINE	477-27-0	COLCHICEINE
SML2Y3J35T	COLCHICINE	64-86-8	Colchicine

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-039-01	16714003901	1 BOTTLE in 1 CARTON (16714-039-01) / 30 TABLET in 1 BOTTLE	1 bottle	2020-11-10	0000-00-00	No	No	Current
16714-039-02	16714003902	1 BOTTLE in 1 CARTON (16714-039-02) / 100 TABLET in 1 BOTTLE	1 bottle	2020-11-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colchicine	A-S Medication Solutions	2024-08-05	HUMAN PRESCRIPTION DRUG LABEL	1
Colchicine	Northstar Rx LLC. \| Zydus Lifesciences Limited	2022-12-09	HUMAN PRESCRIPTION DRUG LABEL	2