Naproxen

Product NDC: 25000-139
Requested package NDC: 25000-139-32
11-digit product format: 250000139
Labeler code: 25000
Product ID: 25000-139_e5013319-e2f4-4cd0-9523-1ffd352fe2d9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET
Route: ORAL
Labeler: MARKSANS PHARMA LIMITED
Application: ANDA091416
Marketing category: ANDA
Marketing start: 2011-02-28
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: 2026-12-31
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
A091416-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14
A091416-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14
A091416-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091416-001	AB
A091416-002	AB
A091416-003	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	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`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	A091416-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091416-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091416-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091416-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091416-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091416-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091416-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091416-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091416-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091416-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091416-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091416-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091416-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091416-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091416-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091416-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091416-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091416-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091416-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091416-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091416-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091416-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091416-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091416-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091416-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091416-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091416-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091416-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091416-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091416-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091416-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091416-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091416-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091416-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091416-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091416-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091416-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091416-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091416-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091416-001	AB	1	`8072bd15b7f6…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NAPROXEN	NAPROXEN	Northwind Health Company, LLC	f32d755e-4984-ee40-e053-2995a90a4ebe	2026-01-01	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	QPharma Inc	c0a4839b-7154-c82c-e053-2a95a90a7e6d	2025-12-03	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	PD-Rx Pharmaceuticals, Inc.	a9f9ce81-9d51-4167-9581-974866a8fe31	2025-10-17	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	DIRECT RX	b1b78c49-82e9-2402-e053-2a95a90ae35f	2025-01-17	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
Naproxen	NAPROXEN	Advanced Rx of Tennessee, LLC	af9a96cf-1cda-8ace-e053-2a95a90a18cc	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
Naproxen	NAPROXEN	MARKSANS PHARMA LIMITED	1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8	2024-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091416 application number: ANDA091416 ndc (package): 25000-139-32 ndc (product): 25000-139 ndc11 (package): 25000013932
NAPROXEN	NAPROXEN	NuCare Pharmaceuticals,Inc.	5487dee2-5c37-4348-e054-00144ff8d46c	2024-07-17	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	NuCare Pharmaceuticals,Inc.	71d4a048-ca50-73db-e053-2a95a90ad465	2024-06-10	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	NuCare Pharmaceuticals,Inc.	69366b55-2687-17a4-e053-2a91aa0a65b3	2024-06-07		Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	Asclemed USA, Inc.	a4fcb411-c918-459b-adc6-06dfa8ed8a50	2022-10-12	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	Aphena Pharma Solutions - Tennessee, LLC	32693390-763b-46dd-b821-65a7bf3c6671	2021-04-26	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	Bryant Ranch Prepack	5d399bf3-db49-411a-91b9-b410d702a65a	2020-12-14	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	TIME CAP LABORATORIES	4350a2d9-5228-460e-b7b1-27e8fa846787	2018-10-09	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416

Additional Listing Data#

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

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
1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8	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
25000-139-03	Naproxen	30 in 1 BOTTLE	TABLET	30	14
25000-139-14	Naproxen	1000 in 1 BOTTLE	TABLET	1000	14
25000-139-22	Naproxen	4 in 1 BOX	TABLET	4	14
25000-139-22	Naproxen	4500 in 1 BAG	TABLET	4500	14
25000-139-32	Naproxen	6 in 1 BOX	TABLET	6	14
25000-139-32	Naproxen	4500 in 1 BAG	TABLET	4500	14
25000-139-98	Naproxen	25300 in 1 BAG	TABLET	25300	14
25000-139-98	Naproxen	1 in 1 BOX	TABLET	1	14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET [MARKSANS PHARMA LIMITED]	4
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET [MARKSANS PHARMA LIMITED]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET [MARKSANS PHARMA LIMITED]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET [MARKSANS PHARMA LIMITED]	4
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN TABLET [MARKSANS PHARMA LIMITED]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
25000-139	NAPROXEN TABLET [MARKSANS PHARMA LIMITED]	14	Current NDC, Legacy NDC, 8 package rows	20241219_1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8.zip

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	1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8	14
198012	naproxen 375 MG Oral Tablet	PSN	1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8	14
198014	naproxen 500 MG Oral Tablet	PSN	1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8	14
198013	naproxen 250 MG Oral Tablet	SCD	1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8	14
198012	naproxen 375 MG Oral Tablet	SCD	1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8	14
198014	naproxen 500 MG Oral Tablet	SCD	1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
25000-139-32	25000013932	6 BAG in 1 BOX (25000-139-32) / 4500 TABLET in 1 BAG	6 bag	2011-02-28	0000-00-00	No	No	Current