Naproxen

Product NDC: 59651-986
11-digit product format: 596510986
Labeler code: 59651
Product ID: 59651-986_edd3093b-122c-41c4-9426-f1da6f21a241
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA075390
Marketing category: ANDA
Marketing start: 2025-05-08
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 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075390-001	NAPROXEN	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB		2001-04-19
A075390-002	NAPROXEN	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB		2001-04-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A075390-001	AB
A075390-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A075390-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2001-04-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075390-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2001-04-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075390-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2001-04-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075390-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2001-04-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075390-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2001-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075390-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2001-04-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075390-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075390-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075390-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075390-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075390-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075390-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075390-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075390-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075390-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075390-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075390-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075390-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075390-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075390-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075390-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075390-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075390-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075390-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075390-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075390-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075390-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075390-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075390-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075390-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075390-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075390-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075390-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075390-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075390-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075390-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075390-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075390-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075390-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075390-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL		2001-04-19	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075390-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075390-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075390-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075390-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075390-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075390-002	AB	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075390-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A075390-002	AB	1	`a50c72e98297…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311915	Internal RxNorm lookup
603103	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
67815abd-5e97-4ccb-ac9b-28c2ef6123e7	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
59651-986-01	Naproxen	100 in 1 BOTTLE	TABLET, DELAYED RELEASE	100		2
59651-986-05	Naproxen	500 in 1 BOTTLE	TABLET, DELAYED RELEASE	500		2

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	Aurobindo Pharma Limited	67815abd-5e97-4ccb-ac9b-28c2ef6123e7	2026-03-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075390 application number: ANDA075390 ndc (product): 59651-986

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
603103	naproxen 375 MG Delayed Release Oral Tablet	PSN	67815abd-5e97-4ccb-ac9b-28c2ef6123e7	2
311915	naproxen 500 MG Delayed Release Oral Tablet	PSN	67815abd-5e97-4ccb-ac9b-28c2ef6123e7	2
603103	naproxen 375 MG Delayed Release Oral Tablet	SCD	67815abd-5e97-4ccb-ac9b-28c2ef6123e7	2
311915	naproxen 500 MG Delayed Release Oral Tablet	SCD	67815abd-5e97-4ccb-ac9b-28c2ef6123e7	2
311915	naproxen (as naproxen sodium) 500 MG Delayed Release Oral Tablet	SY	67815abd-5e97-4ccb-ac9b-28c2ef6123e7	2
603103	naproxen 375 MG (as naproxen sodium 413 MG) Delayed Release Oral Tablet	SY	67815abd-5e97-4ccb-ac9b-28c2ef6123e7	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
59651-986-01	59651098601	100 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-986-01)	2025-05-08	No	No	Current
59651-986-05	59651098605	500 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-986-05)	2025-05-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naproxen	Aurobindo Pharma Limited \| Aurovitas Pharma Taizhou Co.,LTD	2026-03-02	Human Prescription Drug Label	2