Naproxen

Product NDC: 67046-0501
11-digit product format: 670460501
Labeler code: 67046
Product ID: 67046-0501_52b8e491-6479-a1fa-e063-6294a90aea67
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA078250
Marketing category: ANDA
Marketing start: 2026-05-26
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: 2027-12-31
Current FDA listing: Yes

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
A078250-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28
A078250-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28
A078250-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078250-001	AB
A078250-002	AB
A078250-003	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	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078250-002	NAPROXEN	375MG	TABLET / ORAL	AB	2007-03-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078250-003	NAPROXEN	500MG	TABLET / ORAL	AB	2007-03-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078250-001	NAPROXEN	250MG	TABLET / ORAL	AB	2007-03-28	`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	A078250-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078250-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078250-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078250-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078250-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078250-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078250-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078250-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078250-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078250-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078250-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078250-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078250-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078250-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078250-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078250-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078250-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078250-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078250-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078250-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078250-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078250-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078250-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078250-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078250-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078250-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Naproxen
Listing expiration: 2027-12-31

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
52b8e52e-73be-3423-e063-6294a90af6e0	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
67046-0501-3	Naproxen	30 in 1 BLISTER PACK	TABLET	30		1

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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	Unit Dose Solutions, Inc.	55652203-e5f3-78dc-e063-6294a90a3e46	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Coupler LLC	545fe39a-4777-b149-e063-6394a90a53cf	2026-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Coupler LLC	53e6519a-cb52-85e2-e063-6394a90abdcf	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Coupler LLC	52b8e52e-73be-3423-e063-6294a90af6e0	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250 ndc (product): 67046-0501
Naproxen	NAPROXEN	Bryant Ranch Prepack	0041b483-34db-49a6-8665-f87e286cd0b8	2026-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	A-S Medication Solutions	4e97e645-552d-424b-990a-f94349a86f17	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	A-S Medication Solutions	000155a8-709c-44e5-a75f-cd890f3a7caf	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	A-S Medication Solutions	d06db628-f6f0-48e2-b538-69c0837c49e3	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	A-S Medication Solutions	9d28422f-6f25-4f14-9272-e0907c971f33	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Preferred Pharmaceuticals Inc.	87acd650-ea8a-4396-be72-5568c4b1755c	2026-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen Sodium	NAPROXEN SODIUM	Glenmark Pharmaceuticals Inc., USA	6c5bb008-e66f-4ef0-bf84-aca7eb5983e9	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	American Health Packaging	86a3e612-3bfe-432f-9afd-972bb8a6644e	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	A-S Medication Solutions	e63a034d-23ef-458f-88ed-8b6d73699621	2025-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Preferred Pharmaceuticals Inc.	727913f6-9542-4a2d-9318-4b7ff521bffd	2025-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Advanced Rx of Tennessee, LLC	af9aa7a0-e287-5935-e053-2995a90a1d11	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	A-S Medication Solutions	bce23087-f055-4234-b75d-69dd43233190	2024-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Bryant Ranch Prepack	da61463f-f87b-4aba-b538-7264252cadb8	2024-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Bryant Ranch Prepack	1fe9a6fc-940e-4a18-b3e9-b204fd67f263	2024-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	Boswell Pharmacy Services LLC d/b/a BPS Wholesale	205b1159-06e5-0d48-e063-6294a90acbd8	2024-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250
Naproxen	NAPROXEN	NuCare Pharmaceuticals, Inc.	46dd3908-6feb-4f50-e054-00144ff88e88	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078250 application number: ANDA078250

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	52b8e52e-73be-3423-e063-6294a90af6e0	1
198014	naproxen 500 MG Oral Tablet	SCD	52b8e52e-73be-3423-e063-6294a90af6e0	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
67046-0501-3	67046050103	30 TABLET in 1 BLISTER PACK (67046-0501-3)	30 tablet	2026-05-26	No	No	Current