Naproxen Sodium

Product NDC: 33358-259
11-digit product format: 333580259
Labeler code: 33358
Product ID: 33358-259_e68706af-547f-4a60-8dc7-25e8f09e36dd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET
Route: ORAL
Labeler: RxChange Co.
Application: ANDA078432
Marketing category: ANDA
Marketing start: 2014-11-11
Marketing end: 0000-00-00
Substance: NAPROXEN SODIUM
Active strength: 550 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	33358-259		I	Inactivated by FDA	2026-10-05
excluded package	package	33358-259	33358-259-00	I	Inactivated by FDA	2026-10-05
excluded package	package	33358-259	33358-259-30	I	Inactivated by FDA	2026-10-05
excluded package	package	33358-259	33358-259-60	I	Inactivated by FDA	2026-10-05
excluded package	package	33358-259	33358-259-90	I	Inactivated by FDA	2026-10-05

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 2 · 110 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	33358-259-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33358-259-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33358-259-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	33358-259-00	`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	33358-259-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33358-259-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33358-259-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	33358-259-00	`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	33358-259-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33358-259-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33358-259-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	33358-259-00	`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	33358-259-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33358-259-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33358-259-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	33358-259-00	`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	33358-259-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33358-259-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33358-259-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	33358-259-00	`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	33358-259-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33358-259-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33358-259-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	33358-259-00	`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	33358-259-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33358-259-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33358-259-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	33358-259-00	`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	33358-259-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33358-259-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33358-259-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	33358-259-00	`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	33358-259-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33358-259-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33358-259-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	33358-259-00	`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	33358-259-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33358-259-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33358-259-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	33358-259-00	`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	33358-259-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33358-259-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33358-259-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	33358-259-00	`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	33358-259-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33358-259-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33358-259-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	33358-259-00	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078432-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL			2007-04-25
A078432-002	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL			2007-04-25

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		2007-04-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		2007-04-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		2007-04-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		2007-04-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		2007-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		2007-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		2007-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		2007-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		2007-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		2007-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		2007-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		2007-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		2007-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		2007-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		2007-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		2007-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078432-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078432-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078432-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078432-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078432-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078432-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078432-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078432-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078432-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078432-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078432-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078432-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078432-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078432-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078432-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078432-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078432-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078432-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078432-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078432-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078432-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078432-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078432-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078432-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078432-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078432-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078432-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078432-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078432-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078432-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078432-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078432-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078432-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078432-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078432-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078432-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078432-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078432-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078432-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078432-002	AB	1	`b00525d2431f…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fef6ad89-235f-4274-ba49-a8e53642473e	Product name	2	20250225
87fed3e6-8fba-48ef-96b0-3a7fb54b96ff	Product name	3	20230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8	Product name	1	20200623
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
6f4f4521-fd56-1ae6-888b-3b021bd75c7c	Product name	1	20140508
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
33358-259-00	Naproxen Sodium Tablets, USP 275 mg and 550 mg
33358-259-30	Naproxen Sodium Tablets, USP 275 mg and 550 mg
33358-259-60	Naproxen Sodium Tablets, USP 275 mg and 550 mg
33358-259-90	Naproxen Sodium Tablets, USP 275 mg and 550 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
33358-259-00	Naproxen Sodium	100 in 1 BOTTLE	TABLET	100	2
33358-259-30	Naproxen Sodium	30 in 1 BOTTLE	TABLET	30	2
33358-259-60	Naproxen Sodium	60 in 1 BOTTLE	TABLET	60	2
33358-259-90	Naproxen Sodium	90 in 1 BOTTLE	TABLET	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
33358-259-00	EA - Each	33358-259	0fba164e-efff-4d76-9d9b-fd32d9b32fae	1	2014-12-01
33358-259-30	EA - Each	33358-259	55cce4b3-984e-4c91-a6df-123cd22a0a82	1	2014-12-01
33358-259-60	EA - Each	33358-259	cb9f2dc9-fddf-45d7-a09b-225da8372ea0	1	2014-12-01
33358-259-90	EA - Each	33358-259	814efca9-9f0a-4ffd-a891-a9d73023f174	1	2015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM TABLET [RXCHANGE CO.]	2
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM TABLET [RXCHANGE CO.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN SODIUM TABLET [RXCHANGE CO.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN SODIUM TABLET [RXCHANGE CO.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN SODIUM TABLET [RXCHANGE CO.]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	NAPROXEN SODIUM TABLET [RXCHANGE CO.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN SODIUM TABLET [RXCHANGE CO.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN SODIUM TABLET [RXCHANGE CO.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN SODIUM TABLET [RXCHANGE CO.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
33358-259	NAPROXEN SODIUM TABLET [RXCHANGE CO.]	2	Legacy NDC, 4 package rows	20141112_ab88c208-6178-41cf-a6f1-88063e340f39.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9TN87S3A3C	NAPROXEN SODIUM	26159-34-2	NAPROXEN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
849431	naproxen sodium 550 MG Oral Tablet	PSN	ab88c208-6178-41cf-a6f1-88063e340f39	2
849431	naproxen sodium 550 MG Oral Tablet	SCD	ab88c208-6178-41cf-a6f1-88063e340f39	2
849431	naproxen sodium 550 MG (as naproxen 500 MG) Oral Tablet	SY	ab88c208-6178-41cf-a6f1-88063e340f39	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
33358-259-00	33358025900	100 in 1 BOTTLE	Historical
33358-259-30	33358025930	30 in 1 BOTTLE	Historical
33358-259-60	33358025960	60 in 1 BOTTLE	Historical
33358-259-90	33358025990	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naproxen Sodium Tablets, USP 275 mg and 550 mg	RxChange Co.	2014-11-12	HUMAN PRESCRIPTION DRUG LABEL	2