MITIGARE

Product NDC: 59467-318
Requested package NDC: 59467-318-30
11-digit product format: 594670318
Labeler code: 59467
Product ID: 59467-318_a5d596e9-761d-4216-bfed-33189557f935
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Colchicine
Dosage form: CAPSULE
Route: ORAL
Labeler: Hikma Specialty USA Inc.
Application: NDA204820
Marketing category: NDA
Marketing start: 2014-10-01
Marketing end: 0000-00-00
Substance: COLCHICINE
Active strength: 1 mg/1
Pharmacologic classes: Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

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	59467-318	59467-318-30	D	Discontinued by firm		2026-11-10

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 44 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
2026-10-15 13:18:30	2026-09	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204820-001	MITIGARE	0.6MG	CAPSULE / ORAL	AB	RLD, RS	2014-09-26	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N204820-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N204820-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204820-001	AB	1	`caaa826d4ba7…`
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 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N204820-001	8927607	2033-08-22	U-1020	2015-01-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204820-001	9399036	2033-08-22	U-1020	2016-08-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204820-001	9555029	2033-08-22	U-1020	2017-02-14	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204820-001	9675613	2033-08-22	U-1020	2017-06-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N204820-001	9789108	2033-08-22	U-1020	2017-11-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N204820-001	8927607	2033-08-22	U-1020	2015-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204820-001	9399036	2033-08-22	U-1020	2016-08-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204820-001	9555029	2033-08-22	U-1020	2017-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204820-001	9675613	2033-08-22	U-1020	2017-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204820-001	9789108	2033-08-22	U-1020	2017-11-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N204820-001	8927607	2033-08-22	U-1020	2015-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204820-001	9399036	2033-08-22	U-1020	2016-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204820-001	9555029	2033-08-22	U-1020	2017-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204820-001	9675613	2033-08-22	U-1020	2017-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204820-001	9789108	2033-08-22	U-1020	2017-11-13	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
59467-318-01	MITIGARE	100 in 1 BOTTLE	CAPSULE	100	18
59467-318-10	MITIGARE	1000 in 1 BOTTLE	CAPSULE	1000	18
59467-318-30	MITIGARE	30 in 1 BOTTLE	CAPSULE	30	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59467-318-01	EA - Each	59467-318	38aaed50-aa83-4a89-8cf1-159b641b0065	1	2014-11-05
59467-318-10	EA - Each	59467-318	cb588729-aee9-4039-9409-2d670bf67399	1	2014-11-05
59467-318-30	EA - Each	59467-318	e192eeff-abd3-4f81-870d-025fce5ada79	1	2018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
COLCHICINE	ACTIVE INGREDIENT	SML2Y3J35T	MITIGARE (COLCHICINE) CAPSULE [HIKMA AMERICAS, INC.]	8
COLCHICINE	ACTIVE MOIETY	SML2Y3J35T	MITIGARE (COLCHICINE) CAPSULE [HIKMA AMERICAS, INC.]	8
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	MITIGARE (COLCHICINE) CAPSULE [HIKMA AMERICAS, INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	MITIGARE (COLCHICINE) CAPSULE [HIKMA AMERICAS, INC.]	8
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	MITIGARE (COLCHICINE) CAPSULE [HIKMA AMERICAS, INC.]	8
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	MITIGARE (COLCHICINE) CAPSULE [HIKMA AMERICAS, INC.]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	MITIGARE (COLCHICINE) CAPSULE [HIKMA AMERICAS, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	MITIGARE (COLCHICINE) CAPSULE [HIKMA AMERICAS, INC.]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	MITIGARE (COLCHICINE) CAPSULE [HIKMA AMERICAS, INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	MITIGARE (COLCHICINE) CAPSULE [HIKMA AMERICAS, INC.]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	MITIGARE (COLCHICINE) CAPSULE [HIKMA AMERICAS, INC.]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59467-318	MITIGARE (COLCHICINE) CAPSULE [HIKMA SPECIALTY USA INC.]	18	Legacy NDC, 3 package rows	20240523_cb5f9d85-6b81-49f8-bcd6-17b7bfbc10f2.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	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

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	cb5f9d85-6b81-49f8-bcd6-17b7bfbc10f2	18
1550946	MITIGARE 0.6 MG Oral Capsule	PSN	cb5f9d85-6b81-49f8-bcd6-17b7bfbc10f2	18
1550946	colchicine 0.6 MG Oral Capsule [Mitigare]	SBD	cb5f9d85-6b81-49f8-bcd6-17b7bfbc10f2	18
1550940	colchicine 0.6 MG Oral Capsule	SCD	cb5f9d85-6b81-49f8-bcd6-17b7bfbc10f2	18
1550946	Mitigare 0.6 MG Oral Capsule	SY	cb5f9d85-6b81-49f8-bcd6-17b7bfbc10f2	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59467-318-30	59467031830	30 CAPSULE in 1 BOTTLE (59467-318-30)	30 capsule	2018-07-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MITIGARE	Hikma Specialty USA Inc. \| Hikma Pharmaceuticals USA Inc.	2024-05-16	HUMAN PRESCRIPTION DRUG LABEL	18