Colchicine

Product NDC: 0143-3018
11-digit product format: 001433018
Labeler code: 0143
Product ID: 0143-3018_76a875b0-99ff-4f9a-9113-ad5e122b7a79
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Colchicine
Dosage form: CAPSULE
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: NDA204820
Marketing category: NDA
Marketing start: 2014-10-01
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

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
N204820-001	MITIGARE	COLCHICINE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N204820-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N204820-001	8927607	2033-08-22	U-1020	2015-01-20
N204820-001	9399036	2033-08-22	U-1020	2016-08-23
N204820-001	9555029	2033-08-22	U-1020	2017-02-14
N204820-001	9675613	2033-08-22	U-1020	2017-06-20
N204820-001	9789108	2033-08-22	U-1020	2017-11-13

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL		RLD, RS	2014-09-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL		RLD, RS	2014-09-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL		RLD, RS	2014-09-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL		RLD, RS	2014-09-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL		RLD, RS	2014-09-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL		RLD, RS	2014-09-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL		RLD, RS	2014-09-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL		RLD, RS	2014-09-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL		RLD, RS	2014-09-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL		RLD, RS	2014-09-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL		RLD, RS	2014-09-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL		RLD, RS	2014-09-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL		RLD, RS	2014-09-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL		RLD, RS	2014-09-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL		RLD, RS	2014-09-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL		RLD, RS	2014-09-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL		RLD, RS	2014-09-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL		RLD, RS	2014-09-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL		RLD, RS	2014-09-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL		RLD, RS	2014-09-26	`cb3db0bc1861…`

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	N204820-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204820-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204820-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204820-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204820-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204820-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204820-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204820-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204820-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204820-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204820-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204820-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204820-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204820-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N204820-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N204820-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N204820-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N204820-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N204820-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N204820-001	AB	1	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N204820-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204820-001	8927607	2033-08-22	U-1020	2015-01-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204820-001	9399036	2033-08-22	U-1020	2016-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204820-001	9555029	2033-08-22	U-1020	2017-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204820-001	9675613	2033-08-22	U-1020	2017-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204820-001	9789108	2033-08-22	U-1020	2017-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204820-001	8927607	2033-08-22	U-1020	2015-01-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204820-001	9399036	2033-08-22	U-1020	2016-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204820-001	9555029	2033-08-22	U-1020	2017-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204820-001	9675613	2033-08-22	U-1020	2017-06-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204820-001	9789108	2033-08-22	U-1020	2017-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204820-001	8927607	2033-08-22	U-1020	2015-01-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204820-001	9399036	2033-08-22	U-1020	2016-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204820-001	9555029	2033-08-22	U-1020	2017-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204820-001	9675613	2033-08-22	U-1020	2017-06-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204820-001	9789108	2033-08-22	U-1020	2017-11-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204820-001	8927607	2033-08-22	U-1020	2015-01-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204820-001	9399036	2033-08-22	U-1020	2016-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204820-001	9555029	2033-08-22	U-1020	2017-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204820-001	9675613	2033-08-22	U-1020	2017-06-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204820-001	9789108	2033-08-22	U-1020	2017-11-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204820-001	8927607	2033-08-22	U-1020	2015-01-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204820-001	9399036	2033-08-22	U-1020	2016-08-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204820-001	9555029	2033-08-22	U-1020	2017-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204820-001	9675613	2033-08-22	U-1020	2017-06-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204820-001	9789108	2033-08-22	U-1020	2017-11-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204820-001	8927607	2033-08-22	U-1020	2015-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204820-001	9399036	2033-08-22	U-1020	2016-08-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204820-001	9555029	2033-08-22	U-1020	2017-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204820-001	9675613	2033-08-22	U-1020	2017-06-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204820-001	9789108	2033-08-22	U-1020	2017-11-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204820-001	8927607	2033-08-22	U-1020	2015-01-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204820-001	9399036	2033-08-22	U-1020	2016-08-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204820-001	9555029	2033-08-22	U-1020	2017-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204820-001	9675613	2033-08-22	U-1020	2017-06-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204820-001	9789108	2033-08-22	U-1020	2017-11-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204820-001	8927607	2033-08-22	U-1020	2015-01-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204820-001	9399036	2033-08-22	U-1020	2016-08-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204820-001	9555029	2033-08-22	U-1020	2017-02-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204820-001	9675613	2033-08-22	U-1020	2017-06-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204820-001	9789108	2033-08-22	U-1020	2017-11-13	`5bbf6a4d5a75…`

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
1550940	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
ee1583ac-c308-4beb-b602-9ecac4977026	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
0143-3018-01	Colchicine	100 in 1 BOTTLE, PLASTIC	CAPSULE	100	22
0143-3018-10	Colchicine	1000 in 1 BOTTLE, PLASTIC	CAPSULE	1000	22
0143-3018-30	Colchicine	30 in 1 BOTTLE, PLASTIC	CAPSULE	30	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-3018-01	EA - Each	0143-3018	474b9312-f0c0-44dd-9163-30e736c78085	1	2015-02-02
0143-3018-10	EA - Each	0143-3018	c96a9166-e18d-4024-afed-3cf9b8a36116	1	2015-02-02
0143-3018-30	EA - Each	0143-3018	d27add5b-f20c-4d5a-8520-23781e84c9d5	1	2018-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
COLCHICINE	ACTIVE INGREDIENT	SML2Y3J35T	COLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]	11
COLCHICINE	ACTIVE MOIETY	SML2Y3J35T	COLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]	11
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	COLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]	11
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	COLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]	11
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	COLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]	11
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	COLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]	11
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	COLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]	11
GELATIN	INACTIVE INGREDIENT	2G86QN327L	COLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]	11
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	COLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	COLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]	11
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	COLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]	11
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	COLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]	11
WATER	INACTIVE INGREDIENT	059QF0KO0R	COLCHICINE CAPSULE [WEST-WARD PHARMACEUTICAL CORP]	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0143-3018	COLCHICINE CAPSULE [HIKMA PHARMACEUTICALS USA INC.]	21	Current NDC, Legacy NDC, 3 package rows	20240524_ee1583ac-c308-4beb-b602-9ecac4977026.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colchicine	COLCHICINE	Major Pharmaceuticals	19486f52-1c7b-43b8-ba48-0d1a6389fedf	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204820 application number: NDA204820
Colchicine	COLCHICINE	American Health Packaging	2f5e24de-3956-4724-a5d7-fe81dcb07f6e	2025-05-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204820 application number: NDA204820
Colchicine	COLCHICINE	Coupler LLC	2cb88c93-54b8-a548-e063-6294a90a94e6	2025-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204820 application number: NDA204820
Colchicine	COLCHICINE	A-S Medication Solutions	25307250-c16b-4467-9ad0-e6c752c576bd	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204820 application number: NDA204820
Colchicine	COLCHICINE	Hikma Pharmaceuticals USA Inc.	ee1583ac-c308-4beb-b602-9ecac4977026	2024-05-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204820 application number: NDA204820 ndc (product): 0143-3018
MITIGARE	COLCHICINE	Hikma Specialty USA Inc.	cb5f9d85-6b81-49f8-bcd6-17b7bfbc10f2	2024-05-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204820 application number: NDA204820

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
1550940	colchicine 0.6 MG Oral Capsule	PSN	ee1583ac-c308-4beb-b602-9ecac4977026	22
1550940	colchicine 0.6 MG Oral Capsule	SCD	ee1583ac-c308-4beb-b602-9ecac4977026	22
1550940	colchicine 0.6 MG Oral Capsule	PSN	25307250-c16b-4467-9ad0-e6c752c576bd	14
1550940	colchicine 0.6 MG Oral Capsule	SCD	25307250-c16b-4467-9ad0-e6c752c576bd	14
1550940	colchicine 0.6 MG Oral Capsule	PSN	2f5e24de-3956-4724-a5d7-fe81dcb07f6e	7
1550940	colchicine 0.6 MG Oral Capsule	SCD	2f5e24de-3956-4724-a5d7-fe81dcb07f6e	7
1550940	colchicine 0.6 MG Oral Capsule	PSN	19486f52-1c7b-43b8-ba48-0d1a6389fedf	5
1550940	colchicine 0.6 MG Oral Capsule	SCD	19486f52-1c7b-43b8-ba48-0d1a6389fedf	5
1550940	colchicine 0.6 MG Oral Capsule	PSN	2cb88c93-54b8-a548-e063-6294a90a94e6	2
1550940	colchicine 0.6 MG Oral Capsule	SCD	2cb88c93-54b8-a548-e063-6294a90a94e6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0143-3018-01	00143301801	100 CAPSULE in 1 BOTTLE, PLASTIC (0143-3018-01)	100 capsule	2014-10-01	0000-00-00	No	No	Current
0143-3018-10	00143301810	1000 CAPSULE in 1 BOTTLE, PLASTIC (0143-3018-10)	1000 capsule	2014-10-01	0000-00-00	No	No	Current
0143-3018-30	00143301830	30 CAPSULE in 1 BOTTLE, PLASTIC (0143-3018-30)	30 capsule	2018-07-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colchicine	Major Pharmaceuticals	2026-03-18	HUMAN PRESCRIPTION DRUG LABEL	5
Colchicine	American Health Packaging	2025-05-15	HUMAN PRESCRIPTION DRUG LABEL	7
Colchicine	Coupler LLC	2025-03-26	HUMAN PRESCRIPTION DRUG LABEL	2
Colchicine	Bryant Ranch Prepack	2024-07-08	HUMAN PRESCRIPTION DRUG LABEL	14
Colchicine	A-S Medication Solutions	2024-06-05	HUMAN PRESCRIPTION DRUG LABEL	14
Colchicine	Hikma Pharmaceuticals USA Inc.	2024-05-22	HUMAN PRESCRIPTION DRUG LABEL	22