Naproxen

Product NDC: 53217-405
11-digit product format: 532170405
Labeler code: 53217
Product ID: 53217-405_d8a7ed12-2361-443a-929f-bced6ca97bca
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Aidarex Pharmaceuticals LLC
Application: ANDA091432
Marketing category: ANDA
Marketing start: 2018-08-10
Marketing end: 0000-00-00
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: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53217-405		I	Inactivated by FDA		2026-08-10
excluded package	package	53217-405	53217-405-30	I	Inactivated by FDA		2026-08-10

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 · 42 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	53217-405-30	`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	53217-405-30	`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	53217-405-30	`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	53217-405-30	`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	53217-405-30	`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	53217-405-30	`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	53217-405-30	`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	53217-405-30	`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	53217-405-30	`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	53217-405-30	`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	53217-405-30	`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	53217-405-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53217-405-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53217-405-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53217-405-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53217-405-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53217-405-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53217-405-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53217-405-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53217-405-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53217-405-30	`9bebd1f3094a…`	`5416666fcb17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A091432-001	NAPROXEN	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB		2011-09-19
A091432-002	NAPROXEN	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB		2011-09-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091432-001	AB
A091432-002	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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091432-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091432-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091432-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091432-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091432-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091432-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091432-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091432-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091432-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091432-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091432-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091432-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091432-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091432-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091432-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091432-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091432-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091432-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091432-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091432-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091432-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091432-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091432-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091432-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091432-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091432-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091432-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091432-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091432-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091432-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091432-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091432-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091432-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091432-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091432-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091432-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091432-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091432-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091432-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091432-002	AB	1	`782e0a99824c…`

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, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53217-405-30	2020-01-31	C162847	48780-1	9d75b9d0-3604-f424-e053-dadaa90a57ce	Naproxen Delayed-release Tablets USP, 500 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53217-405-30	Naproxen	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53217-405	NAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1	Legacy NDC, 1 package rows	20180825_c89df567-5228-4073-a139-71ee22cf359b.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	Cameron Pharmaceuticals	2ae474dd-eaae-4401-8d42-613d672daea0	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091432 application number: ANDA091432
Naproxen	NAPROXEN	Sunrise Pharmaceutical, Inc.	f2fb222a-b854-4e6f-9027-2e08aed24185	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091432 application number: ANDA091432
Naproxen	NAPROXEN	PD-Rx Pharmaceuticals, Inc.	2d01e583-670a-46f4-b5f2-3fad46d0376f	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091432 application number: ANDA091432
Naproxen	NAPROXEN	Bryant Ranch Prepack	124af155-0661-4054-9800-de547d8212d7	2025-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091432 application number: ANDA091432
Naproxen	NAPROXEN	NuCare Pharmaceuticals,Inc.	5e873524-f9fb-fe2d-e053-2991aa0aa0a5	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091432 application number: ANDA091432
Naproxen	NAPROXEN	Bryant Ranch Prepack	74134b90-d4c7-41bd-a1bd-2ac168db596f	2024-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091432 application number: ANDA091432
Naproxen	NAPROXEN	Proficient Rx LP	69a3afd6-d64b-4f07-b848-b0d3fc19f2a2	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091432 application number: ANDA091432
Naproxen	NAPROXEN	Cipla USA Inc.	e06c2b43-9882-442e-8413-10d9a33aecb9	2019-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091432 application number: ANDA091432

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
57Y76R9ATQ	NAPROXEN	22204-53-1	NAPROXEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311915	naproxen 500 MG Delayed Release Oral Tablet	PSN	c89df567-5228-4073-a139-71ee22cf359b	1
311915	naproxen 500 MG Delayed Release Oral Tablet	SCD	c89df567-5228-4073-a139-71ee22cf359b	1
311915	naproxen (as naproxen sodium) 500 MG Delayed Release Oral Tablet	SY	c89df567-5228-4073-a139-71ee22cf359b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53217-405-30	53217040530	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naproxen Delayed-release Tablets USP, 500 mg Rx only	Aidarex Pharmaceuticals LLC \| Aidarex Pharmaceuticals	2018-08-24	HUMAN PRESCRIPTION DRUG LABEL	1