Treximet

Product NDC: 65224-860
11-digit product format: 652240860
Labeler code: 65224
Product ID: 65224-860_146f2017-7356-4ccf-8c0c-65b1eb53df8f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sumatriptan Succinate and Naproxen Sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Pernix Therapeutics
Application: NDA021926
Marketing category: NDA
Marketing start: 2015-05-14
Marketing end: 2021-09-30
Substance: SUMATRIPTAN SUCCINATE; NAPROXEN SODIUM
Active strength: 10 mg/1; mg/1
Pharmacologic classes: Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC],Serotonin 1b Receptor Agonists [MoA],Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	65224-860		D	Discontinued by firm		2026-08-17
excluded package	package	65224-860	65224-860-09	D	Discontinued by firm		2026-08-17

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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65224-860-09	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65224-860-09	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65224-860-09	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65224-860-09	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65224-860-09	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65224-860-09	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65224-860-09	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65224-860-09	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65224-860-09	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65224-860-09	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65224-860-09	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65224-860-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	65224-860-09	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021926-001	TREXIMET	NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE	500MG;EQ 85MG BASE	TABLET / ORAL	AB	RLD, RS	2008-04-15
N021926-002	TREXIMET	NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE	60MG;EQ 10MG BASE	TABLET / ORAL		RLD	2015-05-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021926-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021926-001	7332183	2025-10-02	U-867	Drug product
N021926-001	7332183*PED	2026-04-02		Pediatric extension
N021926-002	7332183	2025-10-02	U-1719	Drug product	2015-07-27
N021926-002	7332183*PED	2026-04-02		Pediatric extension

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 3 · 84 observed 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
2026-08-18 06:07:40	2026-07	N021926-001	TREXIMET	500MG;EQ 85MG BASE	TABLET / ORAL	AB	RLD, RS	2008-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021926-002	TREXIMET	60MG;EQ 10MG BASE	TABLET / ORAL		RLD	2015-05-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021926-001	TREXIMET	500MG;EQ 85MG BASE	TABLET / ORAL	AB	RLD, RS	2008-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021926-002	TREXIMET	60MG;EQ 10MG BASE	TABLET / ORAL		RLD	2015-05-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021926-001	TREXIMET	500MG;EQ 85MG BASE	TABLET / ORAL	AB	RLD, RS	2008-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021926-002	TREXIMET	60MG;EQ 10MG BASE	TABLET / ORAL		RLD	2015-05-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021926-001	TREXIMET	500MG;EQ 85MG BASE	TABLET / ORAL	AB	RLD, RS	2008-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021926-002	TREXIMET	60MG;EQ 10MG BASE	TABLET / ORAL		RLD	2015-05-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021926-001	TREXIMET	500MG;EQ 85MG BASE	TABLET / ORAL	AB	RLD, RS	2008-04-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021926-002	TREXIMET	60MG;EQ 10MG BASE	TABLET / ORAL		RLD	2015-05-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021926-001	TREXIMET	500MG;EQ 85MG BASE	TABLET / ORAL	AB	RLD, RS	2008-04-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021926-002	TREXIMET	60MG;EQ 10MG BASE	TABLET / ORAL		RLD	2015-05-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021926-001	TREXIMET	500MG;EQ 85MG BASE	TABLET / ORAL	AB	RLD, RS	2008-04-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021926-002	TREXIMET	60MG;EQ 10MG BASE	TABLET / ORAL		RLD	2015-05-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021926-001	TREXIMET	500MG;EQ 85MG BASE	TABLET / ORAL	AB	RLD, RS	2008-04-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021926-002	TREXIMET	60MG;EQ 10MG BASE	TABLET / ORAL		RLD	2015-05-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021926-001	TREXIMET	500MG;EQ 85MG BASE	TABLET / ORAL	AB	RLD, RS	2008-04-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021926-002	TREXIMET	60MG;EQ 10MG BASE	TABLET / ORAL		RLD	2015-05-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021926-001	TREXIMET	500MG;EQ 85MG BASE	TABLET / ORAL	AB	RLD, RS	2008-04-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021926-002	TREXIMET	60MG;EQ 10MG BASE	TABLET / ORAL		RLD	2015-05-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021926-001	TREXIMET	500MG;EQ 85MG BASE	TABLET / ORAL	AB	RLD, RS	2008-04-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021926-002	TREXIMET	60MG;EQ 10MG BASE	TABLET / ORAL		RLD	2015-05-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021926-001	TREXIMET	500MG;EQ 85MG BASE	TABLET / ORAL	AB	RLD, RS	2008-04-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021926-002	TREXIMET	60MG;EQ 10MG BASE	TABLET / ORAL		RLD	2015-05-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021926-001	TREXIMET	500MG;EQ 85MG BASE	TABLET / ORAL	AB	RLD, RS	2008-04-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021926-002	TREXIMET	60MG;EQ 10MG BASE	TABLET / ORAL		RLD	2015-05-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021926-001	TREXIMET	500MG;EQ 85MG BASE	TABLET / ORAL	AB	RLD, RS	2008-04-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021926-002	TREXIMET	60MG;EQ 10MG BASE	TABLET / ORAL		RLD	2015-05-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021926-001	TREXIMET	500MG;EQ 85MG BASE	TABLET / ORAL	AB	RLD, RS	2008-04-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021926-002	TREXIMET	60MG;EQ 10MG BASE	TABLET / ORAL		RLD	2015-05-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021926-001	TREXIMET	500MG;EQ 85MG BASE	TABLET / ORAL	AB	RLD, RS	2008-04-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021926-002	TREXIMET	60MG;EQ 10MG BASE	TABLET / ORAL		RLD	2015-05-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021926-001	TREXIMET	500MG;EQ 85MG BASE	TABLET / ORAL	AB	RLD, RS	2008-04-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021926-002	TREXIMET	60MG;EQ 10MG BASE	TABLET / ORAL		RLD	2015-05-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021926-001	TREXIMET	500MG;EQ 85MG BASE	TABLET / ORAL	AB	RLD, RS	2008-04-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021926-002	TREXIMET	60MG;EQ 10MG BASE	TABLET / ORAL		RLD	2015-05-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021926-001	TREXIMET	500MG;EQ 85MG BASE	TABLET / ORAL	AB	RLD, RS	2008-04-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021926-002	TREXIMET	60MG;EQ 10MG BASE	TABLET / ORAL		RLD	2015-05-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021926-001	TREXIMET	500MG;EQ 85MG BASE	TABLET / ORAL	AB	RLD, RS	2008-04-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021926-002	TREXIMET	60MG;EQ 10MG BASE	TABLET / ORAL		RLD	2015-05-14	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021926-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021926-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021926-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021926-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021926-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021926-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021926-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021926-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021926-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021926-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021926-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021926-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021926-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021926-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021926-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021926-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021926-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021926-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021926-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021926-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021926-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021926-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021926-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021926-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021926-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021926-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021926-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021926-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021926-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021926-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021926-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021926-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021926-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021926-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021926-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021926-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021926-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021926-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021926-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021926-001	AB	1	`e64feba35796…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021926-001	7332183	2025-10-02	U-867	Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021926-001	7332183*PED	2026-04-02		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021926-002	7332183	2025-10-02	U-1719	Drug product	2015-07-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021926-002	7332183*PED	2026-04-02		Pediatric extension		`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021926-001	7332183	2025-10-02	U-867	Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021926-001	7332183*PED	2026-04-02		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021926-002	7332183	2025-10-02	U-1719	Drug product	2015-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021926-002	7332183*PED	2026-04-02		Pediatric extension		`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021926-001	7332183	2025-10-02	U-867	Drug product		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021926-001	7332183*PED	2026-04-02		Pediatric extension		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021926-002	7332183	2025-10-02	U-1719	Drug product	2015-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021926-002	7332183*PED	2026-04-02		Pediatric extension		`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021926-001	7332183	2025-10-02	U-867	Drug product		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021926-001	7332183*PED	2026-04-02		Pediatric extension		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021926-002	7332183	2025-10-02	U-1719	Drug product	2015-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021926-002	7332183*PED	2026-04-02		Pediatric extension		`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021926-001	7332183	2025-10-02	U-867	Drug product		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021926-001	7332183*PED	2026-04-02		Pediatric extension		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021926-002	7332183	2025-10-02	U-1719	Drug product	2015-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021926-002	7332183*PED	2026-04-02		Pediatric extension		`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021926-001	7332183	2025-10-02	U-867	Drug product		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021926-001	7332183*PED	2026-04-02		Pediatric extension		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021926-002	7332183	2025-10-02	U-1719	Drug product	2015-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021926-002	7332183*PED	2026-04-02		Pediatric extension		`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021926-001	7332183	2025-10-02	U-867	Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021926-001	7332183*PED	2026-04-02		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021926-002	7332183	2025-10-02	U-1719	Drug product	2015-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021926-002	7332183*PED	2026-04-02		Pediatric extension		`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021926-001	7332183	2025-10-02	U-867	Drug product		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021926-001	7332183*PED	2026-04-02		Pediatric extension		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021926-002	7332183	2025-10-02	U-1719	Drug product	2015-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021926-002	7332183*PED	2026-04-02		Pediatric extension		`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021926-001	7332183	2025-10-02	U-867	Drug product		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021926-001	7332183*PED	2026-04-02		Pediatric extension		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021926-002	7332183	2025-10-02	U-1719	Drug product	2015-07-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021926-002	7332183*PED	2026-04-02		Pediatric extension		`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021926-001	7332183	2025-10-02	U-867	Drug product		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021926-001	7332183*PED	2026-04-02		Pediatric extension		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021926-002	7332183	2025-10-02	U-1719	Drug product	2015-07-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021926-002	7332183*PED	2026-04-02		Pediatric extension		`d8e5a09893c0…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65224-860-09	EA - Each	65224-860	67bb95e8-50b0-4dce-a97c-db9393685d6e	1	2016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Naproxen Sodium	ACTIVE INGREDIENT	9TN87S3A3C	TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [PERNIX THERAPEUTICS]	18
Sumatriptan Succinate	ACTIVE INGREDIENT	J8BDZ68989	TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [PERNIX THERAPEUTICS]	18
Naproxen	ACTIVE MOIETY	57Y76R9ATQ	TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [PERNIX THERAPEUTICS]	18
Sumatriptan	ACTIVE MOIETY	8R78F6L9VO	TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [PERNIX THERAPEUTICS]	18
Calcium Phosphate, Dibasic, Anhydrous	INACTIVE INGREDIENT	L11K75P92J	TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [PERNIX THERAPEUTICS]	18
Carboxymethylcellulose Sodium, Unspecified Form	INACTIVE INGREDIENT	K679OBS311	TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [PERNIX THERAPEUTICS]	18
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [PERNIX THERAPEUTICS]	18
Croscarmellose Sodium	INACTIVE INGREDIENT	M28OL1HH48	TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [PERNIX THERAPEUTICS]	18
Dextrose Monohydrate	INACTIVE INGREDIENT	LX22YL083G	TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [PERNIX THERAPEUTICS]	18
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [PERNIX THERAPEUTICS]	18
Lecithin, Soybean	INACTIVE INGREDIENT	1DI56QDM62	TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [PERNIX THERAPEUTICS]	18
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [PERNIX THERAPEUTICS]	18
Maltodextrin	INACTIVE INGREDIENT	7CVR7L4A2D	TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [PERNIX THERAPEUTICS]	18
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [PERNIX THERAPEUTICS]	18
Polyvinyl Alcohol	INACTIVE INGREDIENT	532B59J990	TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [PERNIX THERAPEUTICS]	18
Povidones	INACTIVE INGREDIENT	FZ989GH94E	TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [PERNIX THERAPEUTICS]	18
Sodium Bicarbonate	INACTIVE INGREDIENT	8MDF5V39QO	TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [PERNIX THERAPEUTICS]	18
Talc	INACTIVE INGREDIENT	7SEV7J4R1U	TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [PERNIX THERAPEUTICS]	18
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TREXIMET (SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM) TABLET, FILM COATED [PERNIX THERAPEUTICS]	18

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
Sumatriptan Succinate and Naproxen Sodium	SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM	Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven	5762bbe6-bddf-495c-adf8-9096f98a3a9c	2024-12-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021926 application number: NDA021926
Treximet	SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM	Currax Pharmaceuticals LLC	42ddf376-8dc0-4236-be2a-0c6ae92ece04	2024-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021926 application number: NDA021926

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J8BDZ68989	SUMATRIPTAN SUCCINATE	103628-48-4	SUMATRIPTAN SUCCINATE
9TN87S3A3C	NAPROXEN SODIUM	26159-34-2	NAPROXEN SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65224-860-09	65224086009	9 TABLET, FILM COATED in 1 BOTTLE (65224-860-09)	2015-05-14	2021-09-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Treximet	Pernix Therapeutics \| Glaxo Wellcome Manufacturing Pte Ltd \| Glaxo Operations UK Ltd \| GlaxoSmithKline LLC \| Divis Laboratories Limited \| Albemarle Corporation \| Industrias Quimicas Falcon de Mexico, S.A. de C.V. (Dr. Reddy's Mexico)	2020-01-27	HUMAN PRESCRIPTION DRUG LABEL	22