Gloperba

Product NDC: 72690-010
11-digit product format: 726900010
Labeler code: 72690
Product ID: 72690-010_3a77b97f-df41-4712-9b4d-93a9fa64e3c2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: colchicine
Dosage form: SOLUTION
Route: ORAL
Labeler: ROMEG Therapeutics, LLC
Application: NDA210942
Marketing category: NDA
Marketing start: 2019-08-01
Marketing end: 0000-00-00
Substance: COLCHICINE
Active strength: 1 mg/5mL
Pharmacologic classes: Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Interactions [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

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 product	product	72690-010		I	Inactivated by FDA		2026-08-03
excluded package	package	72690-010	72690-010-05	I	Inactivated by FDA		2026-08-03

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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72690-010-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72690-010-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72690-010-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72690-010-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72690-010-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72690-010-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72690-010-05	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72690-010-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72690-010-05	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72690-010-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	72690-010-05	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	72690-010-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	72690-010-05	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	72690-010-05	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	72690-010-05	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	72690-010-05	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	72690-010-05	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	72690-010-05	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	72690-010-05	`8dfbde2a14a4…`	`c9ff85d89658…`

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
N210942-001	GLOPERBA	COLCHICINE	0.6MG/5ML	SOLUTION / ORAL		RLD, RS	2019-01-30

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210942-001	10383820	2036-11-22	U-2814	Drug product	2019-08-28
N210942-001	10383821	2036-11-22		Drug product	2019-08-28
N210942-001	12274751	2036-11-22	U-2814		2025-04-25
N210942-001	12514819	2036-11-22	U-2814		2026-02-03
N210942-001	9907751	2036-11-22		Drug product	2019-02-26
N210942-001	10226423	2037-12-20		Drug product	2019-03-27

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210942-001	GLOPERBA	0.6MG/5ML	SOLUTION / ORAL	RLD, RS	2019-01-30	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 162 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210942-001	10383820	2036-11-22	U-2814	Drug product	2019-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210942-001	10383821	2036-11-22		Drug product	2019-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210942-001	12274751	2036-11-22	U-2814		2025-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210942-001	12514819	2036-11-22	U-2814		2026-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210942-001	9907751	2036-11-22		Drug product	2019-02-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210942-001	10226423	2037-12-20		Drug product	2019-03-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210942-001	10383820	2036-11-22	U-2814	Drug product	2019-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210942-001	10383821	2036-11-22		Drug product	2019-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210942-001	12274751	2036-11-22	U-2814		2025-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210942-001	9907751	2036-11-22		Drug product	2019-02-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210942-001	10226423	2037-12-20		Drug product	2019-03-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210942-001	10383820	2036-11-22	U-2814	Drug product	2019-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210942-001	10383821	2036-11-22		Drug product	2019-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210942-001	12274751	2036-11-22	U-2814		2025-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210942-001	9907751	2036-11-22		Drug product	2019-02-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210942-001	10226423	2037-12-20		Drug product	2019-03-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210942-001	10383820	2036-11-22	U-2814	Drug product	2019-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210942-001	10383821	2036-11-22		Drug product	2019-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210942-001	9907751	2036-11-22		Drug product	2019-02-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210942-001	10226423	2037-12-20		Drug product	2019-03-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210942-001	10383820	2036-11-22	U-2814	Drug product	2019-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210942-001	10383821	2036-11-22		Drug product	2019-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210942-001	9907751	2036-11-22		Drug product	2019-02-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210942-001	10226423	2037-12-20		Drug product	2019-03-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210942-001	10383820	2036-11-22	U-2814	Drug product	2019-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210942-001	10383821	2036-11-22		Drug product	2019-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210942-001	9907751	2036-11-22		Drug product	2019-02-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210942-001	10226423	2037-12-20		Drug product	2019-03-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210942-001	10383820	2036-11-22	U-2814	Drug product	2019-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210942-001	10383821	2036-11-22		Drug product	2019-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210942-001	9907751	2036-11-22		Drug product	2019-02-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210942-001	10226423	2037-12-20		Drug product	2019-03-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210942-001	10383820	2036-11-22	U-2814	Drug product	2019-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210942-001	10383821	2036-11-22		Drug product	2019-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210942-001	9907751	2036-11-22		Drug product	2019-02-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210942-001	10226423	2037-12-20		Drug product	2019-03-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210942-001	10383820	2036-11-22	U-2814	Drug product	2019-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210942-001	10383821	2036-11-22		Drug product	2019-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210942-001	9907751	2036-11-22		Drug product	2019-02-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210942-001	10226423	2037-12-20		Drug product	2019-03-27	`d8e5a09893c0…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72690-010-05	2021-01-29	C162847	48780-1	ba0f9c33-0fd0-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use GLOPERBA ® safely and effectively. See full prescribing information for GLOPERBA ® . GLOPERBA ® (colchicine) Oral Solution Initial U.S. Approval: 1961

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72690-010-05	Gloperba	150 mL in 1 BOTTLE, PLASTIC	SOLUTION	150		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72690-010	GLOPERBA (COLCHICINE) SOLUTION [ROMEG THERAPEUTICS, LLC]	1	Legacy NDC, 1 package rows	20190801_6971137c-deef-4309-909e-552f1930999d.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
Gloperba	COLCHICINE	Scilex Pharmaceuticals Inc.	467cd83f-d695-4040-9434-10e80b4271da	2024-11-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210942 application number: NDA210942

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
2118892	colchicine 0.6 MG in 5 mL Oral Solution	PSN	6971137c-deef-4309-909e-552f1930999d	1
2180558	Gloperba 0.6 MG in 5 mL Oral Solution	PSN	6971137c-deef-4309-909e-552f1930999d	1
2180558	colchicine 0.12 MG/ML Oral Solution [Gloperba]	SBD	6971137c-deef-4309-909e-552f1930999d	1
2118892	colchicine 0.12 MG/ML Oral Solution	SCD	6971137c-deef-4309-909e-552f1930999d	1
2118892	colchicine 0.6 MG per 5 mL Oral Solution	SY	6971137c-deef-4309-909e-552f1930999d	1
2180558	Gloperba 0.12 MG/ML Oral Solution	SY	6971137c-deef-4309-909e-552f1930999d	1
2180558	Gloperba 0.6 MG per 5 mL Oral Solution	SY	6971137c-deef-4309-909e-552f1930999d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
72690-010-05	72690001005	150 mL in 1 BOTTLE, PLASTIC	150 ml	Historical