Naproxen

Product NDC: 67046-1553
Requested package NDC: 67046-1553-3
11-digit product format: 670461553
Labeler code: 67046
Product ID: 67046-1553_3375e0d7-07c2-6489-e063-6294a90a91ec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA200429
Marketing category: ANDA
Marketing start: 2025-04-23
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 129 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
2026-09-14 22:38:34	2026-08	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200429-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200429-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200429-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-11-08	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A200429-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200429-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200429-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200429-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200429-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200429-003	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
3375e139-d9de-8c2d-e063-6394a90a653d	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	Strength	SPL version
67046-1553-3	Naproxen	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67046-1553	NAPROXEN TABLET [COUPLER LLC]	1	Current NDC, 1 package rows	20250425_3375e139-d9de-8c2d-e063-6394a90a653d.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
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 ndc (package): 67046-1553-3 ndc (product): 67046-1553 ndc11 (package): 67046155303
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
198014	naproxen 500 MG Oral Tablet	PSN	3375e139-d9de-8c2d-e063-6394a90a653d	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	Sample	Exclude flag	Status
67046-1553-3	67046155303	30 TABLET in 1 BLISTER PACK (67046-1553-3)	30 tablet	2025-04-23	No	No	Current