Naproxen

Product NDC: 85534-0023
11-digit product format: 855340023
Labeler code: 85534
Product ID: 85534-0023_5524403b-dd49-46cf-e063-6294a90af278
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET
Route: ORAL
Labeler: HAWAII REPACK, INC.
Application: ANDA212517
Marketing category: ANDA
Marketing start: 2020-03-01
Substance: NAPROXEN
Active strength: 375 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 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
A212517-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21
A212517-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21
A212517-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212517-001	AB
A212517-002	AB
A212517-003	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 3 · 117 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	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 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	A212517-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212517-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212517-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212517-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212517-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212517-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212517-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212517-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212517-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212517-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212517-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212517-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212517-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212517-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212517-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212517-001	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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPROXEN	375 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
888efc91-b4de-4691-b84c-fb871e7a6dfe	Available on FDA.report

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 2 of 2 · 40 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	Northwind Health Company, LLC	c986ba9a-6f48-8347-e053-2a95a90aa1c1	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	PHOENIX RX LLC	43912294-77c9-eda8-e063-6394a90adf0a	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	A-S Medication Solutions	8c3398bd-66b1-4a14-8aaa-e4a2d6749a08	2025-11-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Medcore LLC	129392c8-8ce1-4b78-8863-042db880095f	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	A-S Medication Solutions	cfa88511-40bb-4658-b606-44c68d0746b7	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	A-S Medication Solutions	b500bdba-946a-41ff-855c-1f2937547d01	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Proficient Rx LP	e64b3b36-f96e-463e-aca8-8f6e86724bcf	2025-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	A-S Medication Solutions	7fef9311-471b-472c-b4f2-c952a2b3a255	2025-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Asclemed USA, Inc.	1e406e47-408a-48cc-921e-52882a11581c	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Direct_Rx	f499a207-02c8-a338-e053-2995a90accc0	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Advanced Rx Pharmacy of Tennessee, LLC	d292f376-1844-b01c-e053-2a95a90a0927	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Quality Care Products, LLC	1acfb8cc-6faf-4b3e-9304-4819c42de0a6	2024-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Advanced Rx Pharmacy of Tennessee, LLC	1431b769-5535-78d6-e063-6394a90a8423	2024-03-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Asclemed USA, Inc.	5a48c0d4-37bf-4c26-a9a7-5c67ff2adb4b	2024-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Medsource Pharmaceuticals	12648efc-3be8-a915-e063-6394a90a3620	2024-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Bryant Ranch Prepack	1cdcaba5-5550-40f6-94cc-b0a98cc17d3c	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Bryant Ranch Prepack	d564f52d-171c-4e7d-974c-3a0e192e6c12	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Proficient Rx LP	d0670241-f1f9-4fdf-83d4-547e7b800811	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Aphena Pharma Solutions - Tennessee, LLC	98efdeb8-ea38-456e-953f-ba589727f284	2021-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Aphena Pharma Solutions - Tennessee, LLC	9c963e77-6e05-47d0-a8d3-e581777377b9	2021-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517

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	Sample	Exclude flag	Status
85534-0023-0	85534002300	30 TABLET in 1 BOTTLE (85534-0023-0)	30 tablet	2026-06-25	No	No	Current
85534-0023-1	85534002301	60 TABLET in 1 BOTTLE (85534-0023-1)	60 tablet	2026-06-25	No	No	Current
85534-0023-2	85534002302	90 TABLET in 1 BOTTLE (85534-0023-2)	90 tablet	2026-06-25	No	No	Current
85534-0023-3	85534002303	120 TABLET in 1 BOTTLE (85534-0023-3)	120 tablet	2026-06-25	No	No	Current