Naproxen

Product NDC: 43353-201
11-digit product format: 433530201
Labeler code: 43353
Product ID: 43353-201_9d397bfd-f53e-42ca-8e0f-5392b6324e15
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA091305
Marketing category: ANDA
Marketing start: 2012-01-23
Marketing end: 0000-00-00
Substance: NAPROXEN
Active strength: 250 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: 2020-12-31
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	43353-201		D	Discontinued by firm		2026-08-17
excluded package	package	43353-201	43353-201-70	D	Discontinued by firm		2026-08-17

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	Approval date
A091305-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	2011-08-24
A091305-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	2011-08-24
A091305-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	2011-08-24

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091305-002	NAPROXEN	375MG	TABLET / ORAL	2011-08-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091305-003	NAPROXEN	500MG	TABLET / ORAL	2011-08-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091305-001	NAPROXEN	250MG	TABLET / ORAL	2011-08-24	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091305-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091305-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091305-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091305-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091305-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091305-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091305-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091305-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091305-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091305-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091305-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091305-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091305-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091305-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091305-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091305-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091305-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091305-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091305-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091305-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091305-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091305-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091305-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091305-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091305-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091305-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091305-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091305-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091305-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091305-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091305-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091305-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091305-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091305-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091305-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091305-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091305-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091305-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091305-003	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091305-001	AB	1	`6a51e52b5d6a…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-201	NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC	20160714_84ee4538-e051-4a6e-b961-c1a40ca09d1b.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
naproxen	NAPROXEN	Cipla USA Inc.	a9549a47-3fa4-4a2b-95ac-b00e43aedae7	2023-01-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091305 application number: ANDA091305
Naproxen	NAPROXEN	Exelan Pharmaceuticals, Inc.	46dbdb95-a0d0-4410-8d64-b22763b12af7	2020-08-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091305 application number: ANDA091305
Naproxen	NAPROXEN	Aphena Pharma Solutions - Tennessee, LLC	e2347581-90da-429a-b17c-cffd0039fb86	2017-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091305 application number: ANDA091305

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-201-70	43353020170	120 TABLET in 1 BOTTLE (43353-201-70)	120 tablet	2016-06-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naproxen Tablets, USP	Aphena Pharma Solutions - Tennessee, LLC	2016-07-13	HUMAN PRESCRIPTION DRUG LABEL	1