Naproxen Sodium

Product NDC: 53002-5330
Requested package NDC: 53002-5330-3
11-digit product format: 530025330
Labeler code: 53002
Product ID: 53002-5330_413964d2-6000-41e6-bf91-fb720224636d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA200629
Marketing category: ANDA
Marketing start: 2011-10-31
Marketing end: 0000-00-00
Substance: NAPROXEN SODIUM
Active strength: 550 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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53002-5330	53002-5330-3	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A200629-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB		2011-10-31
A200629-002	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB		2011-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200629-001	AB
A200629-002	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 · 86 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	A200629-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2011-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200629-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2011-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200629-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2011-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200629-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2011-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200629-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2011-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200629-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2011-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200629-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2011-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200629-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2011-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200629-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2011-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200629-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2011-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200629-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2011-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200629-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2011-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200629-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2011-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200629-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2011-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200629-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2011-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200629-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2011-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200629-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2011-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200629-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2011-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200629-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2011-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200629-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2011-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200629-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2011-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200629-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2011-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200629-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2011-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200629-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2011-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200629-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2011-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200629-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2011-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200629-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2011-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200629-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2011-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200629-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2011-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200629-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2011-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200629-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2011-10-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200629-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2011-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200629-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2011-10-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200629-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2011-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200629-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2011-10-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200629-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2011-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200629-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2011-10-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200629-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2011-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200629-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2011-10-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200629-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2011-10-31	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A200629-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200629-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200629-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200629-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200629-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200629-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200629-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200629-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200629-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200629-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200629-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200629-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200629-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200629-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200629-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200629-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200629-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200629-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200629-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200629-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200629-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200629-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200629-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200629-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200629-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200629-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200629-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200629-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200629-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200629-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200629-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200629-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200629-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200629-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200629-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200629-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200629-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200629-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200629-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200629-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53002-5330-1	2025-01-30	C162847	48780-1	2cef2736-9af8-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
53002-5330-2	2025-01-30	C162847	48780-1	2cef2736-9af8-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976
53002-5330-3	2025-01-30	C162847	48780-1	2cef2736-9af8-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. NAPROXEN SODIUM tablets, for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-5330-1	Naproxen Sodium	10 in 1 BOTTLE	TABLET, FILM COATED	10	1
53002-5330-2	Naproxen Sodium	20 in 1 BOTTLE	TABLET, FILM COATED	20	1
53002-5330-3	Naproxen Sodium	30 in 1 BOTTLE	TABLET, FILM COATED	30	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-5330	NAPROXEN SODIUM TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]	1	Legacy NDC, 3 package rows	20220331_63478341-bcf8-43ea-803f-6d5d10875cfe.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	1c2325f7-1d65-429d-a64d-6ab075df1c20	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200629 application number: ANDA200629
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	0e7697ad-25c6-4405-9f9b-791633cb1ef7	2025-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200629 application number: ANDA200629
Naproxen Sodium	NAPROXEN SODIUM	Aurobindo Pharma Limited	37b264f9-b46d-4635-8fab-246b1e08b653	2025-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200629 application number: ANDA200629
Naproxen Sodium	NAPROXEN SODIUM	Proficient Rx LP	397db794-027c-4a89-993e-07c208b457a3	2020-09-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200629 application number: ANDA200629

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
849431	naproxen sodium 550 MG Oral Tablet	PSN	63478341-bcf8-43ea-803f-6d5d10875cfe	1
849431	naproxen sodium 550 MG Oral Tablet	SCD	63478341-bcf8-43ea-803f-6d5d10875cfe	1
849431	naproxen sodium 550 MG (as naproxen 500 MG) Oral Tablet	SY	63478341-bcf8-43ea-803f-6d5d10875cfe	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-5330-3	53002533003	30 TABLET, FILM COATED in 1 BOTTLE (53002-5330-3)	2021-01-01	0000-00-00	No	No	Current