Gloperba

Product NDC: 69557-222
11-digit product format: 695570222
Labeler code: 69557
Product ID: 69557-222_25e07ab6-c140-6aae-e063-6394a90ac06e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Colchicine
Dosage form: SOLUTION
Route: ORAL
Labeler: Scilex Pharmaceuticals Inc.
Application: NDA210942
Marketing category: NDA
Marketing start: 2024-01-31
Substance: COLCHICINE
Active strength: .6 mg/5mL
Pharmacologic classes: Alkaloid [EPC], Alkaloids [CS]
NDC exclude flag: No
Listing certified through: 2026-12-31
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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Gloperba
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
COLCHICINE	.6 mg/5mL

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2118892	Internal RxNorm lookup
2180558	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
467cd83f-d695-4040-9434-10e80b4271da	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
bf4e8ffd-8f13-3050-5248-581676b7ea42	Product name	6	20221214
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
987af351-b977-4822-ac44-c76d29e24e78	Product name	1	20190611
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
9869efd7-d6dd-0665-5b67-53adbe6ef15e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69557-222-01	Gloperba	150 mL in 1 BOTTLE	SOLUTION	150		3
69557-222-01	Gloperba	1 in 1 CARTON	SOLUTION	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69557-222-01	ML - Milliliter	69557-222	e6a98898-39a9-45d2-b1c6-2c0107287790	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69557-222	GLOPERBA (COLCHICINE) SOLUTION [SCILEX PHARMACEUTICALS INC.]	3	Current NDC, 2 package rows	20241105_467cd83f-d695-4040-9434-10e80b4271da.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 ndc (product): 69557-222

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	467cd83f-d695-4040-9434-10e80b4271da	3
2180558	Gloperba 0.6 MG in 5 mL Oral Solution	PSN	467cd83f-d695-4040-9434-10e80b4271da	3
2180558	colchicine 0.12 MG/ML Oral Solution [Gloperba]	SBD	467cd83f-d695-4040-9434-10e80b4271da	3
2118892	colchicine 0.12 MG/ML Oral Solution	SCD	467cd83f-d695-4040-9434-10e80b4271da	3
2118892	colchicine 0.6 MG per 5 mL Oral Solution	SY	467cd83f-d695-4040-9434-10e80b4271da	3
2180558	Gloperba 0.12 MG/ML Oral Solution	SY	467cd83f-d695-4040-9434-10e80b4271da	3
2180558	Gloperba 0.6 MG per 5 mL Oral Solution	SY	467cd83f-d695-4040-9434-10e80b4271da	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69557-222-01	69557022201	1 BOTTLE in 1 CARTON (69557-222-01) / 150 mL in 1 BOTTLE	1 bottle	2024-01-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gloperba	Scilex Pharmaceuticals Inc. \| Ferndale Laboratories, Inc. \| Indena	2024-11-01	HUMAN PRESCRIPTION DRUG LABEL	3