Naproxen

Product NDC: 65862-522
11-digit product format: 658620522
Labeler code: 65862
Product ID: 65862-522_51d52d13-f5c1-4e80-8cb9-4aa72ad94103
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA200429
Marketing category: ANDA
Marketing start: 2011-11-08
Substance: NAPROXEN
Active strength: 500 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
unfinished product	product	65862-522		UNFINISHED	Active or certified unfinished drug listing		2026-08-12
unfinished package	package	65862-522	65862-522-22	UNFINISHED	Active or certified unfinished drug listing		2026-08-12

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 21:27 UTC · source 2025-12-05	unfinished product	product		`a6255e0c9aa5…`	`a0211a219f2e…`
2025-12-14 21:27 UTC · source 2025-12-05	unfinished package	package	65862-522-22	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished product	product		`1d862106b807…`	`00c93037cd84…`
2025-08-26 23:59 UTC · source 2025-08-26	unfinished package	package	65862-522-22	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished product	product		`390b4c401c3f…`	`2c692c2daee3…`
2025-05-15 14:59 UTC · source 2025-05-14	unfinished package	package	65862-522-22	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished product	product		`e30019b0c005…`	`a3f0b14938b7…`
2025-04-01 07:37 UTC · source 2025-03-31	unfinished package	package	65862-522-22	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished product	product		`bbbc9f937eca…`	`946b9c97cf81…`
2025-03-01 13:19 UTC · source 2025-02-28	unfinished package	package	65862-522-22	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished product	product		`f268b84574a6…`	`26285f5ac5df…`
2025-02-27 05:24 UTC · source 2025-02-26	unfinished package	package	65862-522-22	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished product	product		`f764e8902f78…`	`92046438deef…`
2025-02-01 13:13 UTC · source 2025-01-31	unfinished package	package	65862-522-22	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished product	product		`68b1e3bced9e…`	`98a755eb8bc6…`
2025-01-20 13:05 UTC · source 2025-01-17	unfinished package	package	65862-522-22	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished product	product		`05c55d027831…`	`ca05dca9dc4c…`
2024-11-29 20:42 UTC · source 2024-11-29	unfinished package	package	65862-522-22	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished product	product		`48b4f40e6753…`	`c7c7a00d2afa…`
2024-11-09 02:36 UTC · source 2024-11-08	unfinished package	package	65862-522-22	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished product	product		`27f29a85d7e4…`	`1372111e901f…`
2024-10-09 02:27 UTC · source 2024-10-08	unfinished package	package	65862-522-22	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished product	product		`8d62ce987f31…`	`9fe9ef23e30d…`
2024-07-10 04:00 UTC · source 2024-07-09	unfinished package	package	65862-522-22	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished product	product		`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-28 21:11 UTC · source 2024-05-28	unfinished package	package	65862-522-22	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished product	product		`50b4072663b7…`	`eae3003ed65e…`
2024-05-15 03:51 UTC · source 2024-05-14	unfinished package	package	65862-522-22	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished product	product		`906f6e251498…`	`bf70b80e44f0…`
2022-04-09 23:13 UTC · source 2022-04-08	unfinished package	package	65862-522-22	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished product	product		`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-12-27 23:28 UTC · source 2021-12-27	unfinished package	package	65862-522-22	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished product	product		`8fc7167e32ce…`	`e96bbc724034…`
2021-02-18 23:40 UTC · source 2021-02-18	unfinished package	package	65862-522-22	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished product	product		`4184dd79f89f…`	`545327b3e20f…`
2020-12-18 03:04 UTC · source 2020-12-17	unfinished package	package	65862-522-22	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished product	product		`4bd3596a7b87…`	`5c64c6f6865f…`
2020-06-10 20:45 UTC · source 2020-06-10	unfinished package	package	65862-522-22	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	65862-522-22	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	65862-522-22	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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

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
A200429-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08
A200429-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08
A200429-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200429-001	AB
A200429-002	AB
A200429-003	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 · 123 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	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A200429-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200429-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200429-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200429-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200429-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200429-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200429-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200429-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200429-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200429-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200429-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200429-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200429-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200429-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200429-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200429-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200429-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200429-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200429-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200429-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200429-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200429-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200429-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200429-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200429-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200429-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200429-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200429-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200429-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200429-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200429-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200429-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200429-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200429-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200429-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200429-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200429-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200429-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200429-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200429-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Naproxen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPROXEN	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
57Y76R9ATQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198012	Internal RxNorm lookup
198013	Internal RxNorm lookup
198014	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
0e5315bc-c02f-4749-be69-b5b528327d58	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65862-522-01	Naproxen	100 in 1 BOTTLE	TABLET	100	16
65862-522-05	Naproxen	500 in 1 BOTTLE	TABLET	500	16
65862-522-26	Naproxen	2500 in 1 BOTTLE	TABLET	2500	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-522-01	EA - Each	65862-522	4c3ffeea-fc54-426f-a607-c04e5a189ab1	1	2012-07-24
65862-522-05	EA - Each	65862-522	7c521228-590f-4966-b245-77abeaddaea4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET [AUROBINDO PHARMA LIMITED]	3
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET [AUROBINDO PHARMA LIMITED]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	NAPROXEN TABLET [AUROBINDO PHARMA LIMITED]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	NAPROXEN TABLET [AUROBINDO PHARMA LIMITED]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET [AUROBINDO PHARMA LIMITED]	3
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	NAPROXEN TABLET [AUROBINDO PHARMA LIMITED]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	NAPROXEN TABLET [AUROBINDO PHARMA LIMITED]	3
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NAPROXEN TABLET [AUROBINDO PHARMA LIMITED]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-522	NAPROXEN TABLET [AUROBINDO PHARMA LIMITED]	15	Current NDC, Legacy NDC, 3 package rows	20241213_0e5315bc-c02f-4749-be69-b5b528327d58.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	Bryant Ranch Prepack	e0f430fd-4511-41c8-b5e9-894abe4f3c37	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200429 application number: ANDA200429
Naproxen	NAPROXEN	Aurobindo Pharma Limited	0e5315bc-c02f-4749-be69-b5b528327d58	2025-06-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200429 application number: ANDA200429 ndc (product): 65862-522
Naproxen	NAPROXEN	Coupler LLC	3375e139-d9de-8c2d-e063-6394a90a653d	2025-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200429 application number: ANDA200429
Naproxen	NAPROXEN	Advanced Rx of Tennessee, LLC	af9ac948-4405-5abf-e053-2995a90af2b5	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200429 application number: ANDA200429
Naproxen	NAPROXEN	A-S Medication Solutions	f91c1a6b-b256-42e1-9da0-5f1975dec6ce	2023-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200429 application number: ANDA200429
Naproxen	NAPROXEN	A-S Medication Solutions	a8b54258-84e7-41e8-9e51-137a3f442e6b	2023-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200429 application number: ANDA200429
Naproxen	NAPROXEN	A-S Medication Solutions	50c52976-9e04-4a5e-9f21-aca3ea5c2924	2023-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200429 application number: ANDA200429
Naproxen	NAPROXEN	A-S Medication Solutions	d801ba16-e2ec-4bb2-8cff-32388634b35a	2023-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200429 application number: ANDA200429

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
198013	naproxen 250 MG Oral Tablet	PSN	0e5315bc-c02f-4749-be69-b5b528327d58	16
198012	naproxen 375 MG Oral Tablet	PSN	0e5315bc-c02f-4749-be69-b5b528327d58	16
198014	naproxen 500 MG Oral Tablet	PSN	0e5315bc-c02f-4749-be69-b5b528327d58	16
198013	naproxen 250 MG Oral Tablet	SCD	0e5315bc-c02f-4749-be69-b5b528327d58	16
198012	naproxen 375 MG Oral Tablet	SCD	0e5315bc-c02f-4749-be69-b5b528327d58	16
198014	naproxen 500 MG Oral Tablet	SCD	0e5315bc-c02f-4749-be69-b5b528327d58	16
198014	naproxen 500 MG Oral Tablet	PSN	af9ac948-4405-5abf-e053-2995a90af2b5	6
198014	naproxen 500 MG Oral Tablet	SCD	af9ac948-4405-5abf-e053-2995a90af2b5	6
198014	naproxen 500 MG Oral Tablet	PSN	0b25daa0-a8d6-d7f7-e063-6394a90a2cb0	3
198014	naproxen 500 MG Oral Tablet	SCD	0b25daa0-a8d6-d7f7-e063-6394a90a2cb0	3
198014	naproxen 500 MG Oral Tablet	PSN	e0f430fd-4511-41c8-b5e9-894abe4f3c37	1
198014	naproxen 500 MG Oral Tablet	PSN	d801ba16-e2ec-4bb2-8cff-32388634b35a	1
198014	naproxen 500 MG Oral Tablet	PSN	a8b54258-84e7-41e8-9e51-137a3f442e6b	1
198014	naproxen 500 MG Oral Tablet	PSN	f91c1a6b-b256-42e1-9da0-5f1975dec6ce	1
198014	naproxen 500 MG Oral Tablet	PSN	50c52976-9e04-4a5e-9f21-aca3ea5c2924	1
198014	naproxen 500 MG Oral Tablet	PSN	3375e139-d9de-8c2d-e063-6394a90a653d	1
198014	naproxen 500 MG Oral Tablet	SCD	e0f430fd-4511-41c8-b5e9-894abe4f3c37	1
198014	naproxen 500 MG Oral Tablet	SCD	f91c1a6b-b256-42e1-9da0-5f1975dec6ce	1
198014	naproxen 500 MG Oral Tablet	SCD	d801ba16-e2ec-4bb2-8cff-32388634b35a	1
198014	naproxen 500 MG Oral Tablet	SCD	a8b54258-84e7-41e8-9e51-137a3f442e6b	1
198014	naproxen 500 MG Oral Tablet	SCD	50c52976-9e04-4a5e-9f21-aca3ea5c2924	1
198014	naproxen 500 MG Oral Tablet	SCD	3375e139-d9de-8c2d-e063-6394a90a653d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-522-01	65862052201	100 TABLET in 1 BOTTLE (65862-522-01)	100 tablet	2011-11-08	0000-00-00	No	No	Current
65862-522-05	65862052205	500 TABLET in 1 BOTTLE (65862-522-05)	500 tablet	2011-11-08	0000-00-00	No	No	Current
65862-522-22	65862052222	2000 TABLET in 1 BAG (65862-522-22)	2000 tablet	08-NOV-11				Current
65862-522-26	65862052226	2500 TABLET in 1 BOTTLE (65862-522-26)	2500 tablet	2011-11-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naproxen	Bryant Ranch Prepack	2025-10-13	HUMAN PRESCRIPTION DRUG LABEL	1
Naproxen	Aurobindo Pharma Limited	2025-06-07	Human Prescription Drug Label	16
Naproxen	Coupler LLC	2025-04-23	HUMAN PRESCRIPTION DRUG LABEL	1
Naproxen Tablets	Advanced Rx of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	6
Naproxen	Redpharm Drug	2024-07-24	HUMAN PRESCRIPTION DRUG LABEL	3
Naproxen	A-S Medication Solutions	2023-12-27	Human Prescription Drug Label	1
Naproxen	A-S Medication Solutions	2023-10-23	Human Prescription Drug Label	1
Naproxen	A-S Medication Solutions	2023-09-06	Human Prescription Drug Label	1
Naproxen	A-S Medication Solutions	2023-09-06	Human Prescription Drug Label	1