Colchicine

Product NDC: 59651-455
Requested package NDC: 59651-455-91
11-digit product format: 596510455
Labeler code: 59651
Product ID: 59651-455_eedd0f18-16dc-4404-bc85-507ec93049e9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Colchicine
Dosage form: TABLET
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA215444
Marketing category: ANDA
Marketing start: 2022-03-22
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

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
unfinished package	package	59651-455	59651-455-91	UNFINISHED	Active or certified unfinished drug listing		2026-08-12

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`

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
A215444-001	COLCHICINE	COLCHICINE	0.6MG	TABLET / ORAL	AB		2022-01-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215444-001	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.

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	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215444-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2022-01-06	`a50c72e98297…`

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	A215444-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215444-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215444-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215444-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215444-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215444-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215444-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215444-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215444-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215444-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215444-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215444-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215444-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215444-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215444-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215444-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215444-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215444-001	AB	1	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215444-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215444-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215444-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215444-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215444-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215444-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215444-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215444-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215444-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215444-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215444-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215444-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215444-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215444-001	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
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
dd93a40f-92ab-47ac-9083-b8a7a0b18ad6	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	Strength	SPL version
59651-455-01	Colchicine	100 in 1 BOTTLE	TABLET	100		2
59651-455-30	Colchicine	30 in 1 BOTTLE	TABLET	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59651-455-01	EA - Each	59651-455	e7ea27a1-aa34-4bf6-852a-472632a0e4bf	1	2022-11-07
59651-455-30	EA - Each	59651-455	241899a5-fb55-4f21-b575-2508311b4700	1	2022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-455	COLCHICINE TABLET [AUROBINDO PHARMA LIMITED]	1	Current NDC, Legacy NDC, 2 package rows	20220323_dd93a40f-92ab-47ac-9083-b8a7a0b18ad6.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colchicine	COLCHICINE	Aurobindo Pharma Limited	dd93a40f-92ab-47ac-9083-b8a7a0b18ad6	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215444 application number: ANDA215444 ndc (product): 59651-455

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	dd93a40f-92ab-47ac-9083-b8a7a0b18ad6	2
197541	colchicine 0.6 MG Oral Tablet	SCD	dd93a40f-92ab-47ac-9083-b8a7a0b18ad6	2
197541	colchicine 600 MCG Oral Tablet	SY	dd93a40f-92ab-47ac-9083-b8a7a0b18ad6	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
59651-455-91	59651045591	100000 TABLET in 1 BAG (59651-455-91)	100000 tablet	22-MAR-22	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colchicine	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-07-22	Human Prescription Drug Label	2