Naprelan

Product NDC: 59630-777
11-digit product format: 596300777
Labeler code: 59630
Product ID: 59630-777_00ea44c7-97e5-426f-b0f2-8884e8bfa7dc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Shionogi Inc.
Application: NDA020353
Marketing category: NDA
Marketing start: 1996-04-01
Marketing end: 0000-00-00
Substance: NAPROXEN SODIUM
Active strength: 750 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	59630-777		D	Discontinued by firm		2026-08-11
excluded package	package	59630-777	59630-777-03	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 · 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		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59630-777-03	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59630-777-03	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59630-777-03	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59630-777-03	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59630-777-03	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59630-777-03	D	Discontinued by firm	`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	59630-777-03	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	59630-777-03	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	59630-777-03	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	59630-777-03	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	59630-777-03	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	59630-777-03	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	59630-777-03	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	59630-777-03	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	59630-777-03	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	59630-777-03	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	59630-777-03	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	59630-777-03	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	59630-777-03	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	59630-777-03	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	59630-777-03	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	59630-777-03	I	Inactivated by FDA	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 123 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	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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020353-002	NAPRELAN	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020353-003	NAPRELAN	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	1996-01-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020353-001	NAPRELAN	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	1996-01-05	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020353-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020353-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020353-001	AB	1	`8072bd15b7f6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59630-777-03	2025-02-11	C162847	48780-1	9855d018-e9e1-cd31-e053-dbdaa90ab51a	Naprelan
59630-777-03	2019-11-27	C162847	48780-1	9855d018-e9e1-cd31-e053-dbdaa90ab51a	Naprelan

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59630-777-03	EA - Each	59630-777	dfa4fd9c-994c-493b-8d49-df2f609c5b1b	1	2013-02-13

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 [SHIONOGI INC.]	5
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	5
AMMONIO METHACRYLATE COPOLYMER TYPE A	INACTIVE INGREDIENT	8GQS4E66YY	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	5
AMMONIO METHACRYLATE COPOLYMER TYPE B	INACTIVE INGREDIENT	161H3B14U2	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	5
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	5
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	5
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	5
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPRELAN (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [SHIONOGI INC.]	5

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naprelan	Shionogi Inc. \| ALKERMES PHARMA IRELAND LIMITED	2013-08-22	HUMAN PRESCRIPTION DRUG LABEL	5