NAPROXEN SODIUM DS

Product NDC: 69784-550
11-digit product format: 697840550
Labeler code: 69784
Product ID: 69784-550_e7975860-648a-454a-b324-9d7824f92521
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: naproxen sodium
Dosage form: TABLET
Route: ORAL
Labeler: Woodward Pharma Services LLC
Application: NDA018164
Marketing category: NDA
Marketing start: 2018-10-15
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69784-550		D	Discontinued by firm		2026-10-12
excluded package	package	69784-550	69784-550-01	D	Discontinued by firm		2026-10-12

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69784-550-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69784-550-01	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69784-550-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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
N018164-001	ANAPROX	NAPROXEN SODIUM	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982
N018164-003	ANAPROX DS	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018164-003	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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018164-001	ANAPROX	EQ 250MG BASE	TABLET / ORAL		RLD, Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018164-001	ANAPROX	EQ 250MG BASE	TABLET / ORAL		RLD, Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018164-001	ANAPROX	EQ 250MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL		RLD, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N018164-003	ANAPROX DS	EQ 500MG BASE	TABLET / ORAL	AB	RLD, RS	1987-09-30	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	N018164-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N018164-003	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N018164-003	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69784-550-01	2024-01-30	C162847	48780-1	d6a99b39-6c54-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use NAPROXEN Tablets, EC-NAPROXEN and NAPROXEN SODIUM safely and effectively. See full prescribing information for NAPROXEN, EC-NAPROXEN and NAPROXEN SODIUM. NAPROXEN (naproxen) tablets, EC-NAPROXEN (naproxen delayed-release tablets), NAPROXEN SODIUM (naproxen sodium tablets), for oral use Initial U.S. Approval: 1976
69784-550-01	2022-07-30	C162847	48780-1	d6a99b39-6c54-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use NAPROXEN Tablets, EC-NAPROXEN and NAPROXEN SODIUM safely and effectively. See full prescribing information for NAPROXEN, EC-NAPROXEN and NAPROXEN SODIUM. NAPROXEN (naproxen) tablets, EC-NAPROXEN (naproxen delayed-release tablets), NAPROXEN SODIUM (naproxen sodium tablets), for oral use Initial U.S. Approval: 1976
69784-550-01	2022-01-28	C162847	48780-1	d6a99b39-6c54-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use NAPROXEN Tablets, EC-NAPROXEN and NAPROXEN SODIUM safely and effectively. See full prescribing information for NAPROXEN, EC-NAPROXEN and NAPROXEN SODIUM. NAPROXEN (naproxen) tablets, EC-NAPROXEN (naproxen delayed-release tablets), NAPROXEN SODIUM (naproxen sodium tablets), for oral use Initial U.S. Approval: 1976

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69784-550-01	EA - Each	69784-550	017c5240-1641-4a07-b7ea-2fdb8e076101	1	2018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69784-550	NAPROXEN TABLET EC-NAPROXEN (NAPROXEN) TABLET, DELAYED RELEASE NAPROXEN SODIUM DS (NAPROXEN SODIUM) TABLET [WOODWARD PHARMA SERVICES LLC]	5	Legacy NDC	20240415_0728935b-19fc-4a10-aeba-29c42ce7f472.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69784-550-01	69784055001	100 TABLET in 1 BOTTLE, PLASTIC (69784-550-01)	100 tablet	2018-10-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NAPROXEN	Woodward Pharma Services LLC \| Recipharm Leganes SLU	2024-04-13	HUMAN PRESCRIPTION DRUG LABEL	5