Naprosyn

Product NDC: 69437-316
11-digit product format: 694370316
Labeler code: 69437
Product ID: 69437-316_30e34aeb-4e90-4ba5-adc7-343806b104c6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: naproxen
Dosage form: TABLET
Route: ORAL
Labeler: Canton Laboratories
Application: NDA017581
Marketing category: NDA
Marketing start: 2016-06-01
Marketing end: 0000-00-00
Substance: NAPROXEN
Active strength: 500 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	69437-316		D	Discontinued by firm		2026-10-15
excluded package	package	69437-316	69437-316-01	D	Discontinued by firm		2026-10-15

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	69437-316		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69437-316	69437-316-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	RLD / RS	Approval date
N017581-002	NAPROSYN	NAPROXEN	250MG	TABLET / ORAL		RLD, Approved before 1982
N017581-003	NAPROSYN	NAPROXEN	375MG	TABLET / ORAL		RLD, Approved before 1982
N017581-004	NAPROSYN	NAPROXEN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017581-004	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 · 132 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
2026-10-15 13:18:30	2026-09	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017581-003	NAPROSYN	375MG	TABLET / ORAL		RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N017581-004	NAPROSYN	500MG	TABLET / ORAL	AB	RLD, RS	1982-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017581-002	NAPROSYN	250MG	TABLET / ORAL		RLD, Approved before 1982		`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N017581-004	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017581-004	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017581-004	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017581-004	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69437-316-01	EA - Each	69437-316	5270eaa1-fe43-45f4-a513-4c0e8a6077ab	1	2016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69437-316	NAPROSYN (NAPROXEN) TABLET EC-NAPROSYN (NAPROXEN) TABLET, DELAYED RELEASE ANAPROX DS (NAPROXEN SODIUM) TABLET [CANTON LABORATORIES]	12	Legacy NDC	20250105_8bff5df5-d856-4237-b6a8-ae445b454844.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
57Y76R9ATQ	NAPROXEN	22204-53-1	NAPROXEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69437-316-01	69437031601	100 TABLET in 1 BOTTLE, PLASTIC (69437-316-01)	100 tablet	2016-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naprosyn	Canton Laboratories \| Industrias Quimicas Falcon De Mexico S.A. de C.V.	2025-01-03	HUMAN PRESCRIPTION DRUG LABEL	12