Naproxen sodium

Product NDC: 43598-494
11-digit product format: 435980494
Labeler code: 43598
Product ID: 43598-494_3498dec1-32e7-ecde-c86e-4c1d7cb0b080
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Dr. Reddy's Laboratories Inc.
Application: ANDA078486
Marketing category: ANDA
Marketing start: 2016-04-26
Substance: NAPROXEN SODIUM
Active strength: 275 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078486-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB		2007-07-26
A078486-002	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB		2007-07-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078486-001	AB
A078486-002	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 · 82 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	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078486-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-07-26	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078486-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-07-26	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A078486-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078486-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078486-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078486-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078486-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078486-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078486-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078486-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078486-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078486-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078486-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078486-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078486-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078486-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078486-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078486-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078486-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078486-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078486-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078486-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078486-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078486-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078486-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078486-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078486-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078486-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078486-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078486-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078486-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078486-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078486-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078486-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078486-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078486-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078486-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078486-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078486-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078486-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078486-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078486-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPROXEN SODIUM	275 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9TN87S3A3C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
849398	Internal RxNorm lookup
849431	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
37de42a6-701b-7f6e-e631-519e2ea78b54	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
43598-494-01	Naproxen sodium	100 in 1 BOTTLE	TABLET, FILM COATED	100	12
43598-494-05	Naproxen sodium	500 in 1 BOTTLE	TABLET, FILM COATED	500	12
43598-494-10	Naproxen sodium	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	12
43598-494-30	Naproxen sodium	30 in 1 BOTTLE	TABLET, FILM COATED	30	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-494-01	EA - Each	43598-494	78be580f-e601-455d-986c-29f44573ff7e	1	2016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-494	NAPROXEN SODIUM TABLET, FILM COATED [DR. REDDY'S LABORATORIES INC.]	10	Current NDC, Legacy NDC, 4 package rows	20240724_37de42a6-701b-7f6e-e631-519e2ea78b54.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen sodium	NAPROXEN SODIUM	PHOENIX RX LLC	47d18804-d8d6-8248-e063-6394a90a48a9	2026-02-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078486 application number: ANDA078486
Naproxen sodium	NAPROXEN SODIUM	A-S Medication Solutions	8181bb7a-d917-4388-bcb0-a74671b07b06	2026-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078486 application number: ANDA078486
Naproxen sodium	NAPROXEN SODIUM	Dr. Reddy's Laboratories Inc.	37de42a6-701b-7f6e-e631-519e2ea78b54	2025-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078486 application number: ANDA078486 ndc (product): 43598-494
Naproxen sodium	NAPROXEN SODIUM	Quality Care Products, LLC	e2ed5556-8109-4002-bf8b-827518a84ea4	2024-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078486 application number: ANDA078486
Naproxen sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	42f6a3a0-5a1e-40ca-8949-b8870dd95d2e	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078486 application number: ANDA078486

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9TN87S3A3C	NAPROXEN SODIUM	26159-34-2	NAPROXEN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
849398	naproxen sodium 275 MG Oral Tablet	PSN	37de42a6-701b-7f6e-e631-519e2ea78b54	12
849431	naproxen sodium 550 MG Oral Tablet	PSN	37de42a6-701b-7f6e-e631-519e2ea78b54	12
849398	naproxen sodium 275 MG Oral Tablet	SCD	37de42a6-701b-7f6e-e631-519e2ea78b54	12
849431	naproxen sodium 550 MG Oral Tablet	SCD	37de42a6-701b-7f6e-e631-519e2ea78b54	12
849398	naproxen sodium 275 MG (as naproxen 250 MG) Oral Tablet	SY	37de42a6-701b-7f6e-e631-519e2ea78b54	12
849431	naproxen sodium 550 MG (as naproxen 500 MG) Oral Tablet	SY	37de42a6-701b-7f6e-e631-519e2ea78b54	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-494-01	43598049401	100 TABLET, FILM COATED in 1 BOTTLE (43598-494-01)	2016-04-26	0000-00-00	No	No	Current
43598-494-05	43598049405	500 TABLET, FILM COATED in 1 BOTTLE (43598-494-05)	2016-04-26	0000-00-00	No	No	Current
43598-494-10	43598049410	1000 TABLET, FILM COATED in 1 BOTTLE (43598-494-10)	2016-04-26	0000-00-00	No	No	Current
43598-494-30	43598049430	30 TABLET, FILM COATED in 1 BOTTLE (43598-494-30)	2016-04-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naproxen sodium	Dr. Reddy's Laboratories Inc. \| Dr. Reddy's Laboratories Limited - FTO III	2025-06-11	HUMAN PRESCRIPTION DRUG LABEL	12