colchicine

Product NDC: 70518-4000
Requested package NDC: 70518-4000-1
11-digit product format: 705184000
Labeler code: 70518
Product ID: 70518-4000_540e5750-05bc-13df-e063-6394a90ae5c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: colchicine
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA209876
Marketing category: ANDA
Marketing start: 2024-01-29
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 43.

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.

Product history page 1 of 2 · 42 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
2026-09-14 22:38:34	2026-08	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209876-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2019-09-06	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A209876-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209876-001	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

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
b414be4e-cd4f-4e7d-bbdd-b406c99c11b6	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
70518-4000-0	colchicine	3 in 1 BOTTLE, PLASTIC	TABLET	3		3
70518-4000-1	colchicine	9 in 1 BOTTLE, PLASTIC	TABLET	9		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4000	COLCHICINE TABLET [REMEDYREPACK INC.]	1	Current NDC, 2 package rows	20240515_b414be4e-cd4f-4e7d-bbdd-b406c99c11b6.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 ndc (package): 70518-4000-1 ndc (product): 70518-4000 ndc11 (package): 70518400001
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
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	b414be4e-cd4f-4e7d-bbdd-b406c99c11b6	3
197541	colchicine 0.6 MG Oral Tablet	SCD	b414be4e-cd4f-4e7d-bbdd-b406c99c11b6	3
197541	colchicine 600 MCG Oral Tablet	SY	b414be4e-cd4f-4e7d-bbdd-b406c99c11b6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4000-1	70518400001	9 TABLET in 1 BOTTLE, PLASTIC (70518-4000-1)	9 tablet	2024-05-13	No	No	Current