EC-NAPROXEN

Product NDC: 42494-407
11-digit product format: 424940407
Labeler code: 42494
Product ID: 42494-407_64efd778-d06c-4289-95f6-ae1fbd6efd35
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: naproxen
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Cameron Pharmaceuticals, LLC
Application: NDA020067
Marketing category: NDA
Marketing start: 2016-07-10
Marketing end: 0000-00-00
Substance: NAPROXEN
Active strength: 375 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	42494-407		D	Discontinued by firm		2026-08-17
excluded package	package	42494-407	42494-407-01	D	Discontinued by firm		2026-08-17

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 · 44 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42494-407-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42494-407-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42494-407-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42494-407-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42494-407-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42494-407-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42494-407-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42494-407-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42494-407-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42494-407-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42494-407-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42494-407-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	42494-407-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	42494-407-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	42494-407-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	42494-407-01	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
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	42494-407-01	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	42494-407-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42494-407-01	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42494-407-01	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42494-407-01	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	42494-407-01	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 84 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
2026-08-18 06:07:40	2026-07	N020067-002	EC-NAPROSYN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020067-003	EC-NAPROSYN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1994-10-14	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020067-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020067-003	AB	1	`caaa826d4ba7…`
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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42494-407-01	2020-01-31	C162847	48780-1	9d75b9d0-e1b8-f424-e053-dadaa90a57ce	Naproxen

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42494-407	NAPROXEN TABLET EC-NAPROXEN (NAPROXEN) TABLET, DELAYED RELEASE NAPROXEN SODIUM TABLET NAPROXEN SODIUM DS (NAPROXEN SODIUM) TABLET [CAMERON PHARMACEUTICALS, LLC]	2	Legacy NDC	20160813_b86b31e9-1726-414a-877e-50079c017339.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