EC-Naprosyn

Product NDC: 69437-416
Requested package NDC: 69437-416-01
11-digit product format: 694370416
Labeler code: 69437
Product ID: 69437-416_30e34aeb-4e90-4ba5-adc7-343806b104c6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: naproxen
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Canton Laboratories
Application: NDA020067
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69437-416	69437-416-01	D	Discontinued by firm		2026-08-11

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 · 1 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 package	package	69437-416	69437-416-01	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
N020067-002	EC-NAPROSYN	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14
N020067-003	EC-NAPROSYN	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020067-002	AB
N020067-003	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 · 82 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
2026-02-19 14:30 UTC	2026-02	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`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	N020067-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020067-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020067-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020067-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020067-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020067-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020067-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020067-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020067-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020067-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020067-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020067-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020067-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020067-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020067-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020067-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020067-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020067-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020067-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020067-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020067-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020067-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020067-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020067-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020067-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020067-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020067-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020067-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020067-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020067-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020067-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020067-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020067-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020067-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020067-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020067-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020067-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020067-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020067-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020067-003	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69437-416-01	EA - Each	69437-416	086706f9-88a6-4945-a00e-a9d3a39d687a	1	2016-06-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69437-416	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

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	Zameer Pharmaceuticals LLC	d2e5553a-7c90-407c-9f07-3be65560c23a	2025-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020067 application number: NDA020067

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	Marketing start	Marketing end	Sample	Exclude flag	Status
69437-416-01	69437041601	100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (69437-416-01)	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