Probenecid and Colchicine

Product NDC: 0591-5325
Requested package NDC: 0591-5325-77
11-digit product format: 005915325
Labeler code: 0591
Product ID: 0591-5325_08577252-5289-46f0-80b4-06442a22b332
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Probenecid and Colchicine
Dosage form: TABLET
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA084279
Marketing category: ANDA
Marketing start: 1982-10-01
Substance: COLCHICINE; PROBENECID
Active strength: .5; 500 mg/1; 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	0591-5325	0591-5325-77	UNFINISHED	Active or certified unfinished drug listing		2026-08-10

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 · 11 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…`

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
A084279-001	COL-PROBENECID	COLCHICINE; PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A084279-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084279-001	COL-PROBENECID	0.5MG;500MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A084279-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084279-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084279-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084279-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084279-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084279-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084279-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084279-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084279-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084279-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084279-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084279-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084279-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084279-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084279-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084279-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084279-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084279-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084279-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084279-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084279-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084279-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084279-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084279-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084279-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084279-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084279-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084279-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084279-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084279-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084279-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084279-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084279-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084279-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084279-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084279-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084279-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084279-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084279-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084279-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: Probenecid and Colchicine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PROBENECID	.5 mg/1
COLCHICINE	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
PO572Z7917	Internal UNII lookup
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
198153	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
a0567fe6-132b-463b-bc46-9f5a2a2478fb	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e312405-bfef-73b2-fc56-fea2b3b68305	Product name	2	20250731
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
0591-5325-01	Probenecid and Colchicine	100 in 1 BOTTLE, PLASTIC	TABLET	100		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-5325-01	EA - Each	0591-5325	21727934-fa7b-444f-b5f8-443053e4073e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
COLCHICINE	ACTIVE INGREDIENT	SML2Y3J35T	PROBENECID AND COLCHICINE TABLET [WATSON LABORATORIES, INC.]	2
PROBENECID	ACTIVE INGREDIENT	PO572Z7917	PROBENECID AND COLCHICINE TABLET [WATSON LABORATORIES, INC.]	2
COLCHICINE	ACTIVE MOIETY	SML2Y3J35T	PROBENECID AND COLCHICINE TABLET [WATSON LABORATORIES, INC.]	2
PROBENECID	ACTIVE MOIETY	PO572Z7917	PROBENECID AND COLCHICINE TABLET [WATSON LABORATORIES, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROBENECID AND COLCHICINE TABLET [WATSON LABORATORIES, INC.]	2
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PROBENECID AND COLCHICINE TABLET [WATSON LABORATORIES, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PROBENECID AND COLCHICINE TABLET [WATSON LABORATORIES, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PROBENECID AND COLCHICINE TABLET [WATSON LABORATORIES, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PROBENECID AND COLCHICINE TABLET [WATSON LABORATORIES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-5325	PROBENECID AND COLCHICINE TABLET [ACTAVIS PHARMA, INC.]	7	Current NDC, Legacy NDC, 1 package rows	20240302_a0567fe6-132b-463b-bc46-9f5a2a2478fb.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
Probenecid and Colchicine	PROBENECID AND COLCHICINE	Actavis Pharma, Inc.	a0567fe6-132b-463b-bc46-9f5a2a2478fb	2016-12-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084279 application number: ANDA084279 ndc (product): 0591-5325

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SML2Y3J35T	COLCHICINE	64-86-8	COLCHICINE
PO572Z7917	PROBENECID	57-66-9	PROBENECID

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198153	probenecid 500 MG / colchicine 0.5 MG Oral Tablet	PSN	a0567fe6-132b-463b-bc46-9f5a2a2478fb	7
198153	colchicine 0.5 MG / probenecid 500 MG Oral Tablet	SCD	a0567fe6-132b-463b-bc46-9f5a2a2478fb	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
0591-5325-77	00591532577	17148 TABLET in 1 CONTAINER (0591-5325-77)	17148 tablet	16-SEP-24	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Probenecid and Colchicine Tablets USP Revised: December 2016 Rx only 190813-1	Actavis Pharma, Inc.	2016-12-01	HUMAN PRESCRIPTION DRUG LABEL	7