Sumatriptan Succinate and Naproxen Sodium

Product NDC: 44183-850
11-digit product format: 441830850
Labeler code: 44183
Product ID: 44183-850_e0a82608-7b67-4d15-a04a-16e6c341c621
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sumatriptan succinate and naproxen sodium
Dosage form: TABLET
Route: ORAL
Labeler: Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven
Application: NDA021926
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2015-05-14
Substance: NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Active strength: 500; 85 mg/1; mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Serotonin 1b Receptor Agonists [MoA], Serotonin 1d Receptor Agonists [MoA], Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]
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 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sumatriptan Succinate and Naproxen Sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SUMATRIPTAN SUCCINATE	500 mg/1
NAPROXEN SODIUM	85 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
J8BDZ68989	Internal UNII lookup
9TN87S3A3C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
849450	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
5762bbe6-bddf-495c-adf8-9096f98a3a9c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59adc2ba-d5f0-4a52-b35a-cc77921a79d2	Product name	4	20250724
fef6ad89-235f-4274-ba49-a8e53642473e	Product name	2	20250225
2839c963-7eb3-970a-287f-ff1b6d381268	Product name	2	20250103
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
87fed3e6-8fba-48ef-96b0-3a7fb54b96ff	Product name	3	20230306
1e973b2d-e028-69cd-9258-4613ba80fdc5	Product name	3	20210512
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8	Product name	1	20200623
3eb481d3-8b69-436f-82dd-4a66345568ab	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
c100f0c7-e9dd-42f4-b0a8-0d81bd2a877c	Product name	1	20160303
49615343-b619-4365-8118-8f2ed6046e78	Product name	1	20160224
a6319377-430a-43db-82f9-30d1d9d89cf8	Product name	1	20151216
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
6f4f4521-fd56-1ae6-888b-3b021bd75c7c	Product name	1	20140508
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508
f6199b09-e585-7ceb-4b09-803cf5ce1ed1	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
44183-850-09	Sumatriptan Succinate and Naproxen Sodium	9 in 1 BOTTLE	TABLET	9		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
44183-850-09	EA - Each	44183-850	ce0d465e-8c9b-4c21-8cee-be4c421751ad	1	2018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44183-850	SUMATRIPTAN SUCCINATE AND NAPROXEN SODIUM TABLET [CURRAX PHARMACEUTICALS LLC DBA CYPRESS, HAWTHORN, MACOVEN]	5	Current NDC, Legacy NDC, 1 package rows	20250108_5762bbe6-bddf-495c-adf8-9096f98a3a9c.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
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 ndc (product): 44183-850
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
9TN87S3A3C	NAPROXEN SODIUM	26159-34-2	NAPROXEN SODIUM
J8BDZ68989	SUMATRIPTAN SUCCINATE	103628-48-4	SUMATRIPTAN SUCCINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
849450	SUMAtriptan 85 MG / naproxen sodium 500 MG Oral Tablet	PSN	5762bbe6-bddf-495c-adf8-9096f98a3a9c	5
849450	naproxen sodium 500 MG / sumatriptan 85 MG Oral Tablet	SCD	5762bbe6-bddf-495c-adf8-9096f98a3a9c	5
849450	naproxen sodium 500 MG / sumatriptan (as sumatriptan succinate) 85 MG Oral Tablet	SY	5762bbe6-bddf-495c-adf8-9096f98a3a9c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44183-850-09	44183085009	9 TABLET in 1 BOTTLE (44183-850-09)	9 tablet	2018-02-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sumatriptan Succinate and Naproxen Sodium	Currax Pharmaceuticals LLC dba Cypress, Hawthorn, Macoven \| Cambrex \| Industrias Quimicas Falcon de Mexico, S.A. de C.V. (Dr. Reddy's Mexico) \| Dr. Reddy's Laboratories Limited (India)	2024-12-24	HUMAN PRESCRIPTION DRUG LABEL	5