Colchicine

Product NDC: 49884-171
11-digit product format: 498840171
Labeler code: 49884
Product ID: 49884-171_7503eeb8-f535-4686-b18b-b2d2f61d82a5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: colchicine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Par Health USA, LLC
Application: ANDA203976
Marketing category: ANDA
Marketing start: 2022-09-27
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
A203976-001	COLCHICINE	COLCHICINE	0.6MG	TABLET / ORAL	AB	RS	2021-08-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203976-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	RS	2021-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	RS	2021-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	RS	2021-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	RS	2021-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	RS	2021-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	RS	2021-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	RS	2021-08-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	RS	2021-08-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	RS	2021-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	RS	2021-08-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	RS	2021-08-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	RS	2021-08-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	RS	2021-08-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB		2021-08-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL			2021-08-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL			2021-08-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL			2021-08-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB		2021-08-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB		2021-08-12	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB		2021-08-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB		2021-08-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB		2021-08-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB		2021-08-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB		2021-08-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB		2021-08-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB		2021-08-12	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB		2021-08-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB		2021-08-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL			2021-08-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL			2021-08-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL			2021-08-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL			2021-08-12	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203976-001	COLCHICINE	0.6MG	TABLET / ORAL	AB	RS	2021-08-12	`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	A203976-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203976-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203976-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203976-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203976-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203976-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203976-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203976-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203976-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203976-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203976-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203976-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203976-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203976-001	AB	1	`8072bd15b7f6…`
2022-03-09 01:35 UTC	2022-03	A203976-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203976-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203976-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203976-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203976-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203976-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203976-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203976-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203976-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203976-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203976-001	AB	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203976-001	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
72984aa2-6df9-4460-9926-399ffed30e36	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
49884-171-01	Colchicine	100 in 1 BOTTLE	TABLET, FILM COATED	100		10
49884-171-11	Colchicine	30 in 1 BOTTLE	TABLET, FILM COATED	30		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49884-171-01	EA - Each	49884-171	891da462-94ba-416a-8755-a107f52b6ad8	1	2023-01-09
49884-171-11	EA - Each	49884-171	7e86a0a8-e670-42ff-bd47-c67c0f032a8f	1	2023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49884-171	COLCHICINE TABLET, FILM COATED [ENDO USA, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20240926_72984aa2-6df9-4460-9926-399ffed30e36.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Colchicine	COLCHICINE	American Health Packaging	4b79a786-3f9e-4dad-aa66-bae5f299b966	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203976 application number: ANDA203976
Colchicine	COLCHICINE	Par Health USA, LLC	72984aa2-6df9-4460-9926-399ffed30e36	2025-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203976 application number: ANDA203976 ndc (product): 49884-171

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	72984aa2-6df9-4460-9926-399ffed30e36	10
197541	colchicine 0.6 MG Oral Tablet	SCD	72984aa2-6df9-4460-9926-399ffed30e36	10
197541	colchicine 600 MCG Oral Tablet	SY	72984aa2-6df9-4460-9926-399ffed30e36	10
197541	colchicine 0.6 MG Oral Tablet	PSN	4b79a786-3f9e-4dad-aa66-bae5f299b966	7
197541	colchicine 0.6 MG Oral Tablet	SCD	4b79a786-3f9e-4dad-aa66-bae5f299b966	7
197541	colchicine 600 MCG Oral Tablet	SY	4b79a786-3f9e-4dad-aa66-bae5f299b966	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49884-171-01	49884017101	100 TABLET, FILM COATED in 1 BOTTLE (49884-171-01)	2022-09-27	0000-00-00	No	No	Current
49884-171-11	49884017111	30 TABLET, FILM COATED in 1 BOTTLE (49884-171-11)	2022-09-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colchicine	American Health Packaging	2026-04-09	HUMAN PRESCRIPTION DRUG LABEL	7
Colchicine	Par Health USA, LLC	2026-03-31	HUMAN PRESCRIPTION DRUG LABEL	10