colchicine

Product NDC: 43598-372
11-digit product format: 435980372
Labeler code: 43598
Product ID: 43598-372_1ec57a05-1536-7b6a-a90e-3dd40c9f72d2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: colchicine
Dosage form: TABLET
Route: ORAL
Labeler: Dr.Reddys Laboratories, Inc.
Application: ANDA209876
Marketing category: ANDA
Marketing start: 2020-06-11
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
A209876-001	COLCHICINE	COLCHICINE	0.6MG	TABLET / ORAL	AB		2019-09-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209876-001	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	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`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	A209876-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209876-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209876-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209876-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209876-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209876-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209876-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209876-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209876-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209876-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209876-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209876-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209876-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209876-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209876-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209876-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209876-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209876-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209876-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209876-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209876-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209876-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209876-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209876-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209876-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209876-001	AB	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209876-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209876-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209876-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209876-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209876-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209876-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209876-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209876-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209876-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209876-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209876-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209876-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209876-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A209876-001	AB	1	`a50c72e98297…`

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
2cd5298e-43c6-a8dc-4467-9a3e1ade9307	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
43598-372-01	colchicine	100 in 1 BOTTLE	TABLET	100	11
43598-372-10	colchicine	1000 in 1 BOTTLE	TABLET	1000	11
43598-372-30	colchicine	30 in 1 BOTTLE	TABLET	30	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-372-01	EA - Each	43598-372	6f728fcc-dfaf-420f-8348-ba02da2add4d	1	2020-07-13
43598-372-30	EA - Each	43598-372	72531e20-f2b9-43ac-8fd1-60a40a27283d	1	2020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-372	COLCHICINE TABLET [DR.REDDYS LABORATORIES, INC.]	9	Current NDC, Legacy NDC, 3 package rows	20241115_2cd5298e-43c6-a8dc-4467-9a3e1ade9307.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
colchicine	COLCHICINE	REMEDYREPACK INC.	b414be4e-cd4f-4e7d-bbdd-b406c99c11b6	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209876 application number: ANDA209876
colchicine	COLCHICINE	Dr.Reddys Laboratories, Inc.	2cd5298e-43c6-a8dc-4467-9a3e1ade9307	2025-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209876 application number: ANDA209876 ndc (product): 43598-372
colchicine	COLCHICINE	Proficient Rx LP	0f69b9c6-8c00-45e2-b950-34dc5ae62352	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209876 application number: ANDA209876
COLCHICINE	COLCHICINE	Direct Rx	d92b7189-78fd-693d-e053-2a95a90a7c73	2025-01-21		Exact identifier application applno (ANDA): 209876 application number: ANDA209876
colchicine	COLCHICINE	Bryant Ranch Prepack	14d4be16-d355-4baf-b4cd-4d97d4b2dca0	2023-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209876 application number: ANDA209876

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	14d4be16-d355-4baf-b4cd-4d97d4b2dca0	103
197541	colchicine 0.6 MG Oral Tablet	SCD	14d4be16-d355-4baf-b4cd-4d97d4b2dca0	103
197541	colchicine 600 MCG Oral Tablet	SY	14d4be16-d355-4baf-b4cd-4d97d4b2dca0	103
197541	colchicine 0.6 MG Oral Tablet	PSN	2cd5298e-43c6-a8dc-4467-9a3e1ade9307	11
197541	colchicine 0.6 MG Oral Tablet	SCD	2cd5298e-43c6-a8dc-4467-9a3e1ade9307	11
197541	colchicine 600 MCG Oral Tablet	SY	2cd5298e-43c6-a8dc-4467-9a3e1ade9307	11
197541	colchicine 0.6 MG Oral Tablet	PSN	0f69b9c6-8c00-45e2-b950-34dc5ae62352	4
197541	colchicine 0.6 MG Oral Tablet	SCD	0f69b9c6-8c00-45e2-b950-34dc5ae62352	4
197541	colchicine 600 MCG Oral Tablet	SY	0f69b9c6-8c00-45e2-b950-34dc5ae62352	4
197541	colchicine 0.6 MG Oral Tablet	PSN	b414be4e-cd4f-4e7d-bbdd-b406c99c11b6	3
197541	colchicine 0.6 MG Oral Tablet	PSN	d92b7189-78fd-693d-e053-2a95a90a7c73	3
197541	colchicine 0.6 MG Oral Tablet	SCD	b414be4e-cd4f-4e7d-bbdd-b406c99c11b6	3
197541	colchicine 0.6 MG Oral Tablet	SCD	d92b7189-78fd-693d-e053-2a95a90a7c73	3
197541	colchicine 600 MCG Oral Tablet	SY	b414be4e-cd4f-4e7d-bbdd-b406c99c11b6	3
197541	colchicine 600 MCG Oral Tablet	SY	d92b7189-78fd-693d-e053-2a95a90a7c73	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-372-01	43598037201	100 TABLET in 1 BOTTLE (43598-372-01)	100 tablet	2020-06-11	0000-00-00	No	No	Current
43598-372-10	43598037210	1000 TABLET in 1 BOTTLE (43598-372-10)	1000 tablet	2020-09-04	0000-00-00	No	No	Current
43598-372-30	43598037230	30 TABLET in 1 BOTTLE (43598-372-30)	30 tablet	2020-06-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
colchicine	REMEDYREPACK INC.	2026-06-12	HUMAN PRESCRIPTION DRUG LABEL	4
colchicine	Dr.Reddys Laboratories, Inc. \| Dr. Reddys Laboratories Limited (FTO VII) \| Dr. Reddys Laboratories Limited PU-2	2025-09-01	HUMAN PRESCRIPTION DRUG LABEL	11
colchicine	Proficient Rx LP	2025-07-01	HUMAN PRESCRIPTION DRUG LABEL	4
Colchicine	Direct Rx	2025-01-21	HUMAN PRESCRIPTION DRUG LABEL	3
colchicine	Bryant Ranch Prepack	2023-11-07	HUMAN PRESCRIPTION DRUG LABEL	103