Colchicine

Product NDC: 70518-3851
11-digit product format: 705183851
Labeler code: 70518
Product ID: 70518-3851_43dec4fe-4c65-d38e-e063-6394a90a65b5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Colchicine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA210425
Marketing category: ANDA
Marketing start: 2023-09-02
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-3851	70518-3851-0	D	Discontinued by firm		2026-08-11
excluded package	package	70518-3851	70518-3851-1	D	Discontinued by firm		2026-08-11

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-3851	70518-3851-0	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70518-3851	70518-3851-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70518-3851	70518-3851-1	D	Discontinued by firm	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A210425-001	COLCHICINE	COLCHICINE	0.6MG	TABLET / ORAL	AB		2020-02-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210425-001	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	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210425-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	2020-02-05	`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	A210425-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210425-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210425-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210425-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210425-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210425-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210425-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210425-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210425-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210425-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210425-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210425-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210425-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210425-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210425-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210425-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210425-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210425-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210425-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210425-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210425-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210425-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210425-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210425-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210425-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210425-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210425-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210425-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210425-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210425-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210425-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210425-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210425-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210425-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210425-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210425-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210425-001	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
f818ffe0-43df-4cc6-bc86-00b2c79b06fc	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
70518-3851-0	Colchicine	9 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	9	6
70518-3851-1	Colchicine	6 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	6	6
70518-3851-2	Colchicine	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3851	COLCHICINE TABLET, FILM COATED [REMEDYREPACK INC.]	3	Current NDC, 3 package rows	20240608_f818ffe0-43df-4cc6-bc86-00b2c79b06fc.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.	f818ffe0-43df-4cc6-bc86-00b2c79b06fc	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210425 application number: ANDA210425 ndc (product): 70518-3851
Colchicine	COLCHICINE	Golden State Medical Supply, Inc.	ac12e420-9f29-018e-e053-2a95a90ab612	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210425 application number: ANDA210425
Colchicine	COLCHICINE	Major Pharmaceuticals	9e7c8f65-4722-4187-9014-8fa81eb5681e	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210425 application number: ANDA210425
Colchicine	COLCHICINE	Granules Pharmaceuticals Inc.	dcf97364-b35f-4bc9-8a92-d3d2e05f47ac	2023-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210425 application number: ANDA210425
Colchicine	COLCHICINE	Aphena Pharma Solutions - Tennessee, LLC	b310c57c-9192-4dc8-b76f-2c1982941caf	2020-12-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210425 application number: ANDA210425

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	f818ffe0-43df-4cc6-bc86-00b2c79b06fc	6
197541	colchicine 0.6 MG Oral Tablet	SCD	f818ffe0-43df-4cc6-bc86-00b2c79b06fc	6
197541	colchicine 600 MCG Oral Tablet	SY	f818ffe0-43df-4cc6-bc86-00b2c79b06fc	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70518-3851-0	70518385100	9 in 1 BOTTLE, PLASTIC				Historical
70518-3851-1	70518385101	6 in 1 BOTTLE, PLASTIC				Historical
70518-3851-2	70518385102	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3851-2)	2024-06-06	No	No	Current