Naproxen

Product NDC: 52959-516
11-digit product format: 529590516
Labeler code: 52959
Product ID: 52959-516_8aaccad1-9c53-4d0d-a05f-b1a1f7c77d1f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA075227
Marketing category: ANDA
Marketing start: 2010-09-23
Marketing end: 0000-00-00
Substance: NAPROXEN
Active strength: 500 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 · 10 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-516		I	Inactivated by FDA	2026-08-17
excluded package	package	52959-516	52959-516-02	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-516	52959-516-10	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-516	52959-516-14	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-516	52959-516-15	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-516	52959-516-20	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-516	52959-516-30	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-516	52959-516-40	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-516	52959-516-42	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-516	52959-516-60	I	Inactivated by FDA	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 4 · 220 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-516-42	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-516-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-516-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-516-40	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-516-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-516-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-516-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-516-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-516-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-516-42	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-516-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-516-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-516-40	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-516-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-516-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-516-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-516-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-516-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-516-42	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-516-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-516-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-516-40	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-516-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-516-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-516-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-516-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-516-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-516-42	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-516-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-516-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-516-40	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-516-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-516-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-516-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-516-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-516-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-516-42	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-516-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-516-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-516-40	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-516-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-516-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-516-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-516-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-516-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-516-42	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-516-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-516-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-516-40	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-516-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-516-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-516-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-516-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-516-15	`cdf11ea48f46…`	`ba0047e9e063…`

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
A075227-001	NAPROXEN	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB		1998-06-30
A075227-002	NAPROXEN	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB		1998-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075227-001	AB
A075227-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`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	A075227-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075227-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075227-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075227-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075227-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075227-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075227-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075227-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075227-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075227-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075227-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075227-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075227-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075227-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075227-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075227-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075227-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075227-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075227-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075227-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075227-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075227-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075227-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075227-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075227-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075227-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075227-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075227-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075227-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075227-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075227-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075227-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075227-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075227-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075227-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075227-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075227-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075227-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075227-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075227-002	AB	1	`bb7c543d1eb4…`

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, Related label table
NDC	Related label
52959-516-02	NAPROXEN DELAYED-RELEASE TABLETS USP 1005 1006 Rx only
52959-516-10	NAPROXEN DELAYED-RELEASE TABLETS USP 1005 1006 Rx only
52959-516-14	NAPROXEN DELAYED-RELEASE TABLETS USP 1005 1006 Rx only
52959-516-15	NAPROXEN DELAYED-RELEASE TABLETS USP 1005 1006 Rx only
52959-516-20	NAPROXEN DELAYED-RELEASE TABLETS USP 1005 1006 Rx only
52959-516-30	NAPROXEN DELAYED-RELEASE TABLETS USP 1005 1006 Rx only
52959-516-40	NAPROXEN DELAYED-RELEASE TABLETS USP 1005 1006 Rx only
52959-516-42	NAPROXEN DELAYED-RELEASE TABLETS USP 1005 1006 Rx only
52959-516-60	NAPROXEN DELAYED-RELEASE TABLETS USP 1005 1006 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-516-02	Naproxen	120 in 1 BOTTLE	TABLET, DELAYED RELEASE	120	1
52959-516-10	Naproxen	10 in 1 BOTTLE	TABLET, DELAYED RELEASE	10	1
52959-516-14	Naproxen	14 in 1 BOTTLE	TABLET, DELAYED RELEASE	14	1
52959-516-15	Naproxen	15 in 1 BOTTLE	TABLET, DELAYED RELEASE	15	1
52959-516-20	Naproxen	20 in 1 BOTTLE	TABLET, DELAYED RELEASE	20	1
52959-516-30	Naproxen	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30	1
52959-516-40	Naproxen	40 in 1 BOTTLE	TABLET, DELAYED RELEASE	40	1
52959-516-42	Naproxen	42 in 1 BOTTLE	TABLET, DELAYED RELEASE	42	1
52959-516-60	Naproxen	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-516-02	EA - Each	52959-516	b5ae0c2a-6f12-4877-a423-f631f65a2ff2	1	2012-07-24
52959-516-10	EA - Each	52959-516	01af51a2-8a05-4427-a630-0a9c2df79091	1	2012-07-24
52959-516-14	EA - Each	52959-516	50ae778c-4b02-41de-96f9-04d98f4b50ea	1	2012-07-24
52959-516-15	EA - Each	52959-516	6cd80f54-c373-4cfc-949a-4f9fc7808007	1	2012-07-24
52959-516-20	EA - Each	52959-516	0cb63fe9-406e-4d9b-8ec2-7a282f032bc8	1	2012-07-24
52959-516-30	EA - Each	52959-516	d405b411-63fe-4a78-804a-b8c9cd141028	1	2012-07-24
52959-516-40	EA - Each	52959-516	b2063927-9bfe-4d77-adea-ed199a17bf89	1	2012-07-24
52959-516-42	EA - Each	52959-516	2fab8348-3408-499d-a351-515ef2e16735	1	2012-07-24
52959-516-60	EA - Each	52959-516	0a18f2ce-5756-4613-b487-e736b9c76892	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-516	NAPROXEN TABLET, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]	1	Legacy NDC, 9 package rows	20111207_cce0199c-40e9-4c8c-b04c-c2b969e9a5ba.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
311915	naproxen 500 MG Delayed Release Oral Tablet	PSN	cce0199c-40e9-4c8c-b04c-c2b969e9a5ba	1
311915	naproxen 500 MG Delayed Release Oral Tablet	SCD	cce0199c-40e9-4c8c-b04c-c2b969e9a5ba	1
311915	naproxen (as naproxen sodium) 500 MG Delayed Release Oral Tablet	SY	cce0199c-40e9-4c8c-b04c-c2b969e9a5ba	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-516-02	52959051602	120 in 1 BOTTLE	Historical
52959-516-10	52959051610	10 in 1 BOTTLE	Historical
52959-516-14	52959051614	14 in 1 BOTTLE	Historical
52959-516-15	52959051615	15 in 1 BOTTLE	Historical
52959-516-20	52959051620	20 in 1 BOTTLE	Historical
52959-516-30	52959051630	30 in 1 BOTTLE	Historical
52959-516-40	52959051640	40 in 1 BOTTLE	Historical
52959-516-42	52959051642	42 in 1 BOTTLE	Historical
52959-516-60	52959051660	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NAPROXEN DELAYED-RELEASE TABLETS USP 1005 1006 Rx only	H.J. Harkins Company, Inc. \| Teva Pharmaceuticals USA Inc	2011-10-12	HUMAN PRESCRIPTION DRUG LABEL	1