Naproxen

Product NDC: 0179-1978
11-digit product format: 001791978
Labeler code: 0179
Product ID: 0179-1978_7bea142b-9d60-b634-e053-2991aa0a5cbf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET
Route: ORAL
Labeler: KAISER FOUNDATION HOSPITALS
Application: ANDA078250
Marketing category: ANDA
Marketing start: 2008-10-20
Marketing end: 2020-03-31
Substance: NAPROXEN
Active strength: 500 mg/1
Pharmacologic classes: 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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0179-1978		D	Discontinued by firm	2026-08-17
excluded package	package	0179-1978	0179-1978-01	D	Discontinued by firm	2026-08-17
excluded package	package	0179-1978	0179-1978-30	D	Discontinued by firm	2026-08-17
excluded package	package	0179-1978	0179-1978-50	D	Discontinued by firm	2026-08-17
excluded package	package	0179-1978	0179-1978-60	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 · 60 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	0179-1978-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0179-1978-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0179-1978-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0179-1978-30	`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	0179-1978-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0179-1978-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0179-1978-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0179-1978-30	`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	0179-1978-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0179-1978-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0179-1978-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0179-1978-30	`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	0179-1978-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0179-1978-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0179-1978-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0179-1978-30	`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	0179-1978-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0179-1978-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0179-1978-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0179-1978-30	`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	0179-1978-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0179-1978-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0179-1978-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0179-1978-30	`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	0179-1978-50	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0179-1978-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0179-1978-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0179-1978-30	`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	0179-1978-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0179-1978-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0179-1978-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0179-1978-30	`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	0179-1978-50	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0179-1978-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0179-1978-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0179-1978-30	`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	0179-1978-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0179-1978-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0179-1978-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0179-1978-30	`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	0179-1978-50	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0179-1978-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0179-1978-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0179-1978-30	`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	0179-1978-50	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0179-1978-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0179-1978-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0179-1978-30	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078250-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28
A078250-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28
A078250-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A078250-001	AB
A078250-002	AB
A078250-003	AB

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 4 · 126 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
2026-08-18 06:07:40	2026-07	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A078250-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078250-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078250-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078250-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078250-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078250-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078250-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078250-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078250-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078250-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078250-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078250-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078250-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078250-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078250-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078250-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078250-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078250-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078250-001	AB	1	`1e350fbaab3a…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET [KAISER FOUNDATION HOSPITALS]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET [KAISER FOUNDATION HOSPITALS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NAPROXEN TABLET [KAISER FOUNDATION HOSPITALS]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET [KAISER FOUNDATION HOSPITALS]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET [KAISER FOUNDATION HOSPITALS]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN TABLET [KAISER FOUNDATION HOSPITALS]	1

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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	REMEDYREPACK INC.	88a548d1-97c0-46d0-825a-75ef689d6470	2026-08-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Unit Dose Solutions, Inc.	55652203-e5f3-78dc-e063-6294a90a3e46	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Coupler LLC	545fe39a-4777-b149-e063-6394a90a53cf	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Coupler LLC	53e6519a-cb52-85e2-e063-6394a90abdcf	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Coupler LLC	52b8e52e-73be-3423-e063-6294a90af6e0	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Bryant Ranch Prepack	0041b483-34db-49a6-8665-f87e286cd0b8	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	A-S Medication Solutions	4e97e645-552d-424b-990a-f94349a86f17	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	A-S Medication Solutions	000155a8-709c-44e5-a75f-cd890f3a7caf	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	A-S Medication Solutions	d06db628-f6f0-48e2-b538-69c0837c49e3	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	A-S Medication Solutions	9d28422f-6f25-4f14-9272-e0907c971f33	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Preferred Pharmaceuticals Inc.	87acd650-ea8a-4396-be72-5568c4b1755c	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen Sodium	NAPROXEN SODIUM	Glenmark Pharmaceuticals Inc., USA	6c5bb008-e66f-4ef0-bf84-aca7eb5983e9	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	American Health Packaging	86a3e612-3bfe-432f-9afd-972bb8a6644e	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	A-S Medication Solutions	e63a034d-23ef-458f-88ed-8b6d73699621	2025-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Preferred Pharmaceuticals Inc.	727913f6-9542-4a2d-9318-4b7ff521bffd	2025-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Advanced Rx of Tennessee, LLC	af9aa7a0-e287-5935-e053-2995a90a1d11	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	A-S Medication Solutions	bce23087-f055-4234-b75d-69dd43233190	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Bryant Ranch Prepack	da61463f-f87b-4aba-b538-7264252cadb8	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Bryant Ranch Prepack	1fe9a6fc-940e-4a18-b3e9-b204fd67f263	2024-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	205b1159-06e5-0d48-e063-6294a90acbd8	2024-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250