Naproxen Sodium

Product NDC: 47781-153
11-digit product format: 477810153
Labeler code: 47781
Product ID: 47781-153_6a207289-a8f0-9db1-548f-b55af6131677
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Alvogen Inc.
Application: NDA020353
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2015-03-11
Marketing end: 2027-07-31
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
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

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1116320	Internal RxNorm lookup
1116339	Internal RxNorm lookup
1116349	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
9225acaa-209f-958b-2c51-9a46995dec33	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
47781-153-01	2024-01-30	C162847	48780-1	1030e365-45d8-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use NAPROXEN SODIUM CONTROLLED-RELEASE TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM CONTROLLED-RELEASE TABLETS . NAPROXEN SODIUM Controlled-Release Tablets, for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
47781-153-01	Naproxen Sodium	100 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	100		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47781-153-01	EA - Each	47781-153	a1852f7f-cb1b-4fe9-850d-6819eea08480	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]	1
AMMONIO METHACRYLATE COPOLYMER TYPE A	INACTIVE INGREDIENT	8GQS4E66YY	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]	1
AMMONIO METHACRYLATE COPOLYMER TYPE B	INACTIVE INGREDIENT	161H3B14U2	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]	1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
47781-153	NAPROXEN SODIUM TABLET, FILM COATED, EXTENDED RELEASE [ALVOGEN INC.]	10	Current NDC, Legacy NDC, 1 package rows	20240723_9225acaa-209f-958b-2c51-9a46995dec33.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 ndc (product): 47781-153
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
1116320	naproxen sodium 375 MG 24HR Extended Release Oral Tablet	PSN	9225acaa-209f-958b-2c51-9a46995dec33	11
1116339	naproxen sodium 500 MG 24HR Extended Release Oral Tablet	PSN	9225acaa-209f-958b-2c51-9a46995dec33	11
1116349	naproxen sodium 750 MG 24HR Extended Release Oral Tablet	PSN	9225acaa-209f-958b-2c51-9a46995dec33	11
1116320	24 HR naproxen 375 MG Extended Release Oral Tablet	SCD	9225acaa-209f-958b-2c51-9a46995dec33	11
1116339	24 HR naproxen 500 MG Extended Release Oral Tablet	SCD	9225acaa-209f-958b-2c51-9a46995dec33	11
1116349	24 HR naproxen 750 MG Extended Release Oral Tablet	SCD	9225acaa-209f-958b-2c51-9a46995dec33	11
1116320	naproxen 375 MG (naproxen sodium 413 MG) 24 HR Extended Release Oral Tablet	SY	9225acaa-209f-958b-2c51-9a46995dec33	11
1116339	naproxen 500 MG (naproxen sodium 550 MG) 24 HR Extended Release Oral Tablet	SY	9225acaa-209f-958b-2c51-9a46995dec33	11
1116349	naproxen 750 MG (as naproxen sodium 825 MG) 24 HR Extended Release Oral Tablet	SY	9225acaa-209f-958b-2c51-9a46995dec33	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
47781-153-01	47781015301	100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47781-153-01)	2015-03-11	2027-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naproxen Sodium	Alvogen Inc. \| Norwich Pharmaceuticals, Inc.	2024-07-15	HUMAN PRESCRIPTION DRUG LABEL	11