Naproxen Sodium

Product NDC: 69420-1375
11-digit product format: 694201375
Labeler code: 69420
Product ID: 69420-1375_f34d9d85-4a82-43b6-bf5b-3b2893c6b009
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: SA3, LLC
Application: NDA020353
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2019-05-01
Substance: NAPROXEN SODIUM
Active strength: 375 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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Naproxen Sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPROXEN SODIUM	375 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9TN87S3A3C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1116320	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313dd447-4b9f-4e5b-8ca9-4a2a5a1a53d9	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69420-1375-1	Naproxen Sodium	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69420-1375-1	EA - Each	69420-1375	eaa5a690-03b0-446d-92a8-2fceff8efe91	1	2019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69420-1375	NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [SA3, LLC]	1	Current NDC, Legacy NDC, 1 package rows	20190521_313dd447-4b9f-4e5b-8ca9-4a2a5a1a53d9.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 ndc (product): 69420-1375

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
1116320	naproxen sodium 375 MG 24HR Extended Release Oral Tablet	PSN	313dd447-4b9f-4e5b-8ca9-4a2a5a1a53d9	1
1116320	24 HR naproxen 375 MG Extended Release Oral Tablet	SCD	313dd447-4b9f-4e5b-8ca9-4a2a5a1a53d9	1
1116320	naproxen 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral Tablet	SY	313dd447-4b9f-4e5b-8ca9-4a2a5a1a53d9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69420-1375-1	69420137501	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (69420-1375-1)	2019-05-01	0000-00-00	No	No	Current