Naproxen Sodium

Product NDC: 62037-826
11-digit product format: 620370826
Labeler code: 62037
Product ID: 62037-826_151ee0f3-bd75-4e9f-83b5-12d33ca3b27c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: naproxen sodium
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA075416
Marketing category: ANDA
Marketing start: 2014-09-30
Marketing end: 0000-00-00
Substance: NAPROXEN SODIUM
Active strength: 500 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	62037-826		D	Discontinued by firm		2026-08-17
excluded package	package	62037-826	62037-826-75	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 · 24 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	62037-826-75	`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	62037-826-75	`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	62037-826-75	`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	62037-826-75	`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	62037-826-75	`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	62037-826-75	`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	62037-826-75	`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	62037-826-75	`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	62037-826-75	`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	62037-826-75	`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	62037-826-75	`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	62037-826-75	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	Approval date
A075416-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2002-08-27
A075416-002	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2003-04-23
A075416-003	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075416-001	AB
A075416-002	AB
A075416-003	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075416-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2002-08-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075416-002	NAPROXEN SODIUM	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2003-04-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075416-003	NAPROXEN SODIUM	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-08-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075416-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2002-08-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075416-002	NAPROXEN SODIUM	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2003-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075416-003	NAPROXEN SODIUM	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-08-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075416-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2002-08-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075416-002	NAPROXEN SODIUM	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2003-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075416-003	NAPROXEN SODIUM	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-08-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075416-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2002-08-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075416-002	NAPROXEN SODIUM	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2003-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075416-003	NAPROXEN SODIUM	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-08-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075416-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2002-08-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075416-002	NAPROXEN SODIUM	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2003-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075416-003	NAPROXEN SODIUM	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-08-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075416-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2002-08-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075416-002	NAPROXEN SODIUM	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2003-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075416-003	NAPROXEN SODIUM	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-08-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075416-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2002-08-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075416-002	NAPROXEN SODIUM	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2003-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075416-003	NAPROXEN SODIUM	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-08-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075416-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2002-08-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075416-002	NAPROXEN SODIUM	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2003-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075416-003	NAPROXEN SODIUM	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-08-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075416-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2002-08-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075416-002	NAPROXEN SODIUM	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2003-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075416-003	NAPROXEN SODIUM	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-08-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075416-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2002-08-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075416-002	NAPROXEN SODIUM	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2003-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075416-003	NAPROXEN SODIUM	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-08-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075416-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2002-08-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075416-002	NAPROXEN SODIUM	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2003-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075416-003	NAPROXEN SODIUM	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-08-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075416-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2002-08-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075416-002	NAPROXEN SODIUM	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2003-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075416-003	NAPROXEN SODIUM	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-08-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075416-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2002-08-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075416-002	NAPROXEN SODIUM	EQ 375MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2003-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075416-003	NAPROXEN SODIUM	EQ 750MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2016-08-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075416-001	NAPROXEN SODIUM	EQ 500MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2002-08-27	`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	A075416-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075416-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075416-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075416-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075416-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075416-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075416-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075416-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075416-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075416-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075416-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075416-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075416-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075416-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075416-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075416-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075416-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075416-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075416-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075416-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075416-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075416-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075416-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075416-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075416-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075416-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075416-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075416-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075416-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075416-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075416-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075416-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075416-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075416-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075416-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075416-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075416-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075416-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075416-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075416-001	AB	1	`1e350fbaab3a…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62037-826-75	EA - Each	62037-826	8bc594a6-d7f1-48fb-b3ce-1e4068926951	1	2015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	7
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	7
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)	INACTIVE INGREDIENT	P2OM2Q86BI	NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	7
FUMARIC ACID	INACTIVE INGREDIENT	88XHZ13131	NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	7
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	7
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	7
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	7
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	7

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 Sodium	NAPROXEN SODIUM	Teva Pharmaceuticals, Inc.	826fd9e3-22fe-408b-820c-f2b710189555	2024-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075416 application number: ANDA075416

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
62037-826-75	62037082675	75 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62037-826-75)	2014-09-30	0000-00-00	No	No	Current