NAPRELAN

Product NDC: 21695-905
11-digit product format: 216950905
Labeler code: 21695
Product ID: 21695-905_1f949140-68b5-4602-936f-1936e436d553
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: naproxen sodium
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA020353
Marketing category: NDA
Marketing start: 1996-01-05
Marketing end: 0000-00-00
Substance: NAPROXEN SODIUM
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	21695-905		I	Inactivated by FDA		2026-08-17
excluded package	package	21695-905	21695-905-60	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 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	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	21695-905-60	`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	21695-905-60	`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	21695-905-60	`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	21695-905-60	`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	21695-905-60	`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	21695-905-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	21695-905-60	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	21695-905-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	21695-905-60	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	21695-905-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	21695-905-60	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	21695-905-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-905-60	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-905-60	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-905-60	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-905-60	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-905-60	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-905-60	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-905-60	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-905-60	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-905-60	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-905-60	`110d247fa046…`	`a55b01930146…`

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

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
N020353-001	NAPRELAN	NAPROXEN SODIUM	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05
N020353-002	NAPRELAN	NAPROXEN SODIUM	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05
N020353-003	NAPRELAN	NAPROXEN SODIUM	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-01-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N020353-001	AB
N020353-002	AB
N020353-003	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 4 · 126 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	N020353-001	NAPRELAN	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020353-002	NAPRELAN	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020353-003	NAPRELAN	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-01-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020353-001	NAPRELAN	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020353-002	NAPRELAN	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020353-003	NAPRELAN	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020353-001	NAPRELAN	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020353-002	NAPRELAN	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020353-003	NAPRELAN	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020353-001	NAPRELAN	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020353-002	NAPRELAN	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020353-003	NAPRELAN	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020353-001	NAPRELAN	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020353-002	NAPRELAN	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020353-003	NAPRELAN	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020353-001	NAPRELAN	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020353-002	NAPRELAN	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020353-003	NAPRELAN	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020353-001	NAPRELAN	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020353-002	NAPRELAN	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020353-003	NAPRELAN	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020353-001	NAPRELAN	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020353-002	NAPRELAN	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020353-003	NAPRELAN	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020353-001	NAPRELAN	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020353-002	NAPRELAN	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020353-003	NAPRELAN	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020353-001	NAPRELAN	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020353-002	NAPRELAN	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020353-003	NAPRELAN	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020353-001	NAPRELAN	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020353-002	NAPRELAN	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020353-003	NAPRELAN	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-01-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020353-001	NAPRELAN	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020353-002	NAPRELAN	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020353-003	NAPRELAN	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-01-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020353-001	NAPRELAN	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020353-002	NAPRELAN	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020353-003	NAPRELAN	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-01-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020353-001	NAPRELAN	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	N020353-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020353-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020353-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020353-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020353-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020353-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020353-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020353-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020353-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020353-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020353-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020353-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020353-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020353-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020353-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020353-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020353-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020353-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020353-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020353-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020353-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020353-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020353-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020353-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020353-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020353-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020353-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020353-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020353-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020353-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020353-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020353-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020353-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020353-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020353-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020353-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020353-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020353-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020353-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020353-001	AB	1	`1e350fbaab3a…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fef6ad89-235f-4274-ba49-a8e53642473e	Product name	2	20250225
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
87fed3e6-8fba-48ef-96b0-3a7fb54b96ff	Product name	3	20230306
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8	Product name	1	20200623
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
6f4f4521-fd56-1ae6-888b-3b021bd75c7c	Product name	1	20140508
ce67e27d-1d21-5465-4409-b0662dd99d4d	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-905-60	2019-09-24	C162847	48780-1	934fe258-471c-48b1-e053-8cdaa90a720a	NAPRELAN ® (naproxen sodium) CONTROLLED-RELEASE TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-905-60	NAPRELAN	60 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	60		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-905-60	EA - Each	21695-905	ff59d1e7-2c75-43cb-8575-cd4c11fe3c86	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
naproxen sodium	ACTIVE INGREDIENT	9TN87S3A3C	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
naproxen	ACTIVE MOIETY	57Y76R9ATQ	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
crospovidone	INACTIVE INGREDIENT	68401960MK	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
polyethylene glycol	INACTIVE INGREDIENT	3WJQ0SDW1A	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
povidone	INACTIVE INGREDIENT	FZ989GH94E	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
talc	INACTIVE INGREDIENT	7SEV7J4R1U	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-905	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110104_1f949140-68b5-4602-936f-1936e436d553.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naprelan	NAPROXEN SODIUM	Upsher-Smith Laboratories, LLC	b8a51c9a-488e-4377-a041-436f6a2f8893	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020353 application number: NDA020353
Naproxen Sodium	NAPROXEN SODIUM	Upsher-Smith Laboratories, LLC	7c22a2d6-821c-4f83-aead-e756aed930e5	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020353 application number: NDA020353
Naproxen Sodium	NAPROXEN SODIUM	Alvogen Inc.	9225acaa-209f-958b-2c51-9a46995dec33	2024-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020353 application number: NDA020353
Naprelan	NAPROXEN SODIUM	Almatica Pharma LLC	e633ff0b-eab7-f167-8d08-e9236e54042b	2024-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020353 application number: NDA020353
Naproxen Sodium	NAPROXEN SODIUM	SA3, LLC	313dd447-4b9f-4e5b-8ca9-4a2a5a1a53d9	2019-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020353 application number: NDA020353

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1116331	NAPRELAN 375 MG 24HR Extended Release Oral Tablet	PSN	1f949140-68b5-4602-936f-1936e436d553	1
1116341	NAPRELAN 500 MG 24HR Extended Release Oral Tablet	PSN	1f949140-68b5-4602-936f-1936e436d553	1
1116320	naproxen sodium 375 MG 24HR Extended Release Oral Tablet	PSN	1f949140-68b5-4602-936f-1936e436d553	1
1116339	naproxen sodium 500 MG 24HR Extended Release Oral Tablet	PSN	1f949140-68b5-4602-936f-1936e436d553	1
1116331	24 HR naproxen 375 MG Extended Release Oral Tablet [Naprelan]	SBD	1f949140-68b5-4602-936f-1936e436d553	1
1116341	24 HR naproxen 500 MG Extended Release Oral Tablet [Naprelan]	SBD	1f949140-68b5-4602-936f-1936e436d553	1
1116320	24 HR naproxen 375 MG Extended Release Oral Tablet	SCD	1f949140-68b5-4602-936f-1936e436d553	1
1116339	24 HR naproxen 500 MG Extended Release Oral Tablet	SCD	1f949140-68b5-4602-936f-1936e436d553	1
1116331	24 HR Naprelan 375 MG Extended Release Oral Tablet	SY	1f949140-68b5-4602-936f-1936e436d553	1
1116341	24 HR Naprelan 500 MG Extended Release Oral Tablet	SY	1f949140-68b5-4602-936f-1936e436d553	1
1116331	Naprelan 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral Tablet	SY	1f949140-68b5-4602-936f-1936e436d553	1
1116341	Naprelan 500 MG (naproxen sodium 550 MG) 24 HR Extended Release Oral Tablet	SY	1f949140-68b5-4602-936f-1936e436d553	1
1116320	naproxen 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral Tablet	SY	1f949140-68b5-4602-936f-1936e436d553	1
1116339	naproxen 500 MG (naproxen sodium 550 MG) 24 HR Extended Release Oral Tablet	SY	1f949140-68b5-4602-936f-1936e436d553	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-905-60	21695090560	60 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NAPRELAN ® (naproxen sodium) CONTROLLED-RELEASE TABLETS	Rebel Distributors Corp	2010-12-29	HUMAN PRESCRIPTION DRUG LABEL	1