Naproxen

Product NDC: 43353-216
11-digit product format: 433530216
Labeler code: 43353
Product ID: 43353-216_68ef14c5-d88d-4c95-b6d4-65606f4c11fa
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: 2016-06-10
Substance: NAPROXEN
Active strength: 250 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

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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPROXEN	250 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
e2347581-90da-429a-b17c-cffd0039fb86	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
43353-216-60	Naproxen	90 in 1 BOTTLE	TABLET	90	2
43353-216-70	Naproxen	120 in 1 BOTTLE	TABLET	120	2
43353-216-80	Naproxen	180 in 1 BOTTLE	TABLET	180	2
43353-216-94	Naproxen	360 in 1 BOTTLE	TABLET	360	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-216-60	EA - Each	43353-216	e908ed4a-945e-48c3-8fa8-d784613146c6	1	2017-11-06
43353-216-70	EA - Each	43353-216	7a111ef6-7698-4687-afee-da725bd79810	1	2017-11-06
43353-216-80	EA - Each	43353-216	d1e10135-731d-47e2-b6db-94d5dd27f95b	1	2017-11-06
43353-216-94	EA - Each	43353-216	2be47fef-a404-4618-aef7-ec80d773c2b4	1	2017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-216	NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Current NDC, Legacy NDC, 4 package rows	20171026_e2347581-90da-429a-b17c-cffd0039fb86.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 ndc (product): 43353-216

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	e2347581-90da-429a-b17c-cffd0039fb86	2
198012	naproxen 375 MG Oral Tablet	PSN	e2347581-90da-429a-b17c-cffd0039fb86	2
198014	naproxen 500 MG Oral Tablet	PSN	e2347581-90da-429a-b17c-cffd0039fb86	2
198013	naproxen 250 MG Oral Tablet	SCD	e2347581-90da-429a-b17c-cffd0039fb86	2
198012	naproxen 375 MG Oral Tablet	SCD	e2347581-90da-429a-b17c-cffd0039fb86	2
198014	naproxen 500 MG Oral Tablet	SCD	e2347581-90da-429a-b17c-cffd0039fb86	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-216-60	43353021660	90 TABLET in 1 BOTTLE (43353-216-60)	90 tablet	2016-08-18	0000-00-00	No	No	Current
43353-216-70	43353021670	120 TABLET in 1 BOTTLE (43353-216-70)	120 tablet	2016-08-18	0000-00-00	No	No	Current
43353-216-80	43353021680	180 TABLET in 1 BOTTLE (43353-216-80)	180 tablet	2016-08-22	0000-00-00	No	No	Current
43353-216-94	43353021694	360 TABLET in 1 BOTTLE (43353-216-94)	360 tablet	2016-08-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naproxen - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2017-10-23	HUMAN PRESCRIPTION DRUG LABEL	2