Naproxen Sodium

Product NDC: 53746-194
11-digit product format: 537460194
Labeler code: 53746
Product ID: 53746-194_58c84756-9886-4cfa-937c-f8894064c606
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA078432
Marketing category: ANDA
Marketing start: 2007-04-26
Marketing end: 0000-00-00
Substance: NAPROXEN SODIUM
Active strength: 550 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53746-194		D	Discontinued by firm	2026-10-05
excluded package	package	53746-194	53746-194-01	D	Discontinued by firm	2026-10-05
excluded package	package	53746-194	53746-194-05	D	Discontinued by firm	2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A078432-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL			2007-04-25
A078432-002	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL			2007-04-25

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 3 · 86 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
2026-09-14 22:38:34	2026-08	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		2007-04-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		2007-04-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		2007-04-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		2007-04-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		2007-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		2007-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		2007-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		2007-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		2007-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		2007-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		2007-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		2007-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		2007-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		2007-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL		2007-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL		2007-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078432-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2007-04-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078432-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2007-04-25	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078432-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078432-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078432-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078432-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078432-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078432-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078432-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078432-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078432-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078432-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078432-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078432-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078432-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078432-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078432-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078432-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078432-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078432-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078432-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078432-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078432-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078432-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078432-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078432-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078432-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078432-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078432-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078432-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078432-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078432-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078432-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078432-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078432-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078432-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078432-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078432-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078432-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078432-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078432-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078432-002	AB	1	`b00525d2431f…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fef6ad89-235f-4274-ba49-a8e53642473e	Product name	2	20250225
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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, Related label table
NDC	Effective	Related label
53746-194-01	2021-02-17	These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. N A P R O X E N SODIUM tablets, for oral use Initial U.S. Approval: 1976
53746-194-05	2021-02-17	These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. N A P R O X E N SODIUM tablets, for oral use Initial U.S. Approval: 1976
53746-194-01	2021-01-29	These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. N A P R O X E N SODIUM tablets, for oral use Initial U.S. Approval: 1976
53746-194-05	2021-01-29	These highlights do not include all the information needed to use NAPROXEN SODIUM TABLETS safely and effectively. See full prescribing information for NAPROXEN SODIUM TABLETS. N A P R O X E N SODIUM tablets, for oral use Initial U.S. Approval: 1976

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53746-194-01	EA - Each	53746-194	e4b1b490-7773-4944-b6c8-83b12b4ca8d1	1	2012-07-24
53746-194-05	EA - Each	53746-194	1d1c3c7f-1be6-479a-b0b0-63fcc3732537	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	9
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	9
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	9
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	9
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	9
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	9
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	9
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	9
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	9
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [AVKARE, INC.]	6
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [AVKARE, INC.]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [AVKARE, INC.]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [AVKARE, INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [AVKARE, INC.]	6
Polyethylene Glycols	INACTIVE INGREDIENT	3WJQ0SDW1A	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [AVKARE, INC.]	6
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [AVKARE, INC.]	6
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [AVKARE, INC.]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [AVKARE, INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET [AVKARE, INC.]	6
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM TABLET [AVPAK]	4
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM TABLET [AVPAK]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN SODIUM TABLET [AVPAK]	4
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN SODIUM TABLET [AVPAK]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN SODIUM TABLET [AVPAK]	4
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	NAPROXEN SODIUM TABLET [AVPAK]	4
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN SODIUM TABLET [AVPAK]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN SODIUM TABLET [AVPAK]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN SODIUM TABLET [AVPAK]	4
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]	2
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM TABLET [ATLANTIC BIOLOGICALS CORPS]	2
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM TABLET [RXCHANGE CO.]	2
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM TABLET [RXCHANGE CO.]	2
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM TABLET [ATLANTIC BIOLOGICALS CORPS]	2
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN SODIUM TABLET [RXCHANGE CO.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN SODIUM TABLET [ATLANTIC BIOLOGICALS CORPS]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN SODIUM TABLET [ATLANTIC BIOLOGICALS CORPS]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN SODIUM TABLET [RXCHANGE CO.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN SODIUM TABLET [RXCHANGE CO.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN SODIUM TABLET [ATLANTIC BIOLOGICALS CORPS]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	NAPROXEN SODIUM TABLET [ATLANTIC BIOLOGICALS CORPS]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	NAPROXEN SODIUM TABLET [RXCHANGE CO.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN SODIUM TABLET [RXCHANGE CO.]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN SODIUM TABLET [ATLANTIC BIOLOGICALS CORPS]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN SODIUM TABLET [ATLANTIC BIOLOGICALS CORPS]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN SODIUM TABLET [RXCHANGE CO.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN SODIUM TABLET [ATLANTIC BIOLOGICALS CORPS]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN SODIUM TABLET [RXCHANGE CO.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN SODIUM TABLET [PD-RX PHARMACEUTICALS, INC.]	2
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM (NAPROXEN) TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM TABLET [BRYANT RANCH PREPACK]	1
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM TABLET [PROFICIENT RX LP]	1
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]	1
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]	1
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	NAPROXEN SODIUM CAPSULE [DIRECT RX]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM TABLET [PROFICIENT RX LP]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM TABLET [BRYANT RANCH PREPACK]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM (NAPROXEN) TABLET [NORTHWIND PHARMACEUTICALS, LLC]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN SODIUM CAPSULE [DIRECT RX]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN SODIUM CAPSULE [DIRECT RX]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN SODIUM TABLET [BRYANT RANCH PREPACK]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN SODIUM TABLET [PROFICIENT RX LP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN SODIUM TABLET [PROFICIENT RX LP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN SODIUM TABLET [BRYANT RANCH PREPACK]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN SODIUM CAPSULE [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN SODIUM TABLET [BRYANT RANCH PREPACK]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN SODIUM TABLET [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM SULFATE	INACTIVE INGREDIENT	DE08037SAB	NAPROXEN SODIUM CAPSULE [DIRECT RX]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	NAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	NAPROXEN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	NAPROXEN SODIUM TABLET [BRYANT RANCH PREPACK]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	NAPROXEN SODIUM CAPSULE [DIRECT RX]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	NAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	NAPROXEN SODIUM TABLET [PROFICIENT RX LP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN SODIUM TABLET [BRYANT RANCH PREPACK]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN SODIUM CAPSULE [DIRECT RX]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN SODIUM TABLET [PROFICIENT RX LP]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN SODIUM TABLET [BRYANT RANCH PREPACK]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN SODIUM TABLET [PROFICIENT RX LP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN SODIUM CAPSULE [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN SODIUM CAPSULE [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN SODIUM TABLET [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN SODIUM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN SODIUM TABLET [KELTMAN PHARMACEUTICALS INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN SODIUM TABLET [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN SODIUM TABLET [BRYANT RANCH PREPACK]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53746-194	NAPROXEN SODIUM TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	26	Legacy NDC	20241218_3c55594c-7801-4f59-8f4f-e85a03f3776b.zip

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
849431	naproxen sodium 550 MG Oral Tablet	PSN	82e83f79-3717-4469-8bc8-aea07a7f62b9	3
849431	naproxen sodium 550 MG Oral Tablet	PSN	16705fc3-5379-4557-94b6-fc5bfbbbc6d1	3
849431	naproxen sodium 550 MG Oral Tablet	SCD	82e83f79-3717-4469-8bc8-aea07a7f62b9	3
849431	naproxen sodium 550 MG Oral Tablet	SCD	16705fc3-5379-4557-94b6-fc5bfbbbc6d1	3
849431	naproxen sodium 550 MG (as naproxen 500 MG) Oral Tablet	SY	82e83f79-3717-4469-8bc8-aea07a7f62b9	3
849431	naproxen sodium 550 MG (as naproxen 500 MG) Oral Tablet	SY	16705fc3-5379-4557-94b6-fc5bfbbbc6d1	3
849431	naproxen sodium 550 MG Oral Tablet	PSN	ab88c208-6178-41cf-a6f1-88063e340f39	2
849431	naproxen sodium 550 MG Oral Tablet	SCD	ab88c208-6178-41cf-a6f1-88063e340f39	2
849431	naproxen sodium 550 MG (as naproxen 500 MG) Oral Tablet	SY	ab88c208-6178-41cf-a6f1-88063e340f39	2
849398	naproxen sodium 275 MG Oral Tablet	PSN	30cc16cd-720d-4baa-8941-bfdc28b62b04	1
849431	naproxen sodium 550 MG Oral Tablet	PSN	b91552c0-7de3-4a7a-902b-691eb7ca518b	1
849431	naproxen sodium 550 MG Oral Tablet	PSN	30cc16cd-720d-4baa-8941-bfdc28b62b04	1
849431	naproxen sodium 550 MG Oral Tablet	PSN	0fc2f04c-43a0-4831-b499-369f06a4106a	1
849431	naproxen sodium 550 MG Oral Tablet	PSN	0c01cb34-0d6b-4248-afde-82d4d934dabd	1
849431	naproxen sodium 550 MG Oral Tablet	PSN	7164427d-38b4-6aae-e053-2995a90a0d07	1
849398	naproxen sodium 275 MG Oral Tablet	SCD	30cc16cd-720d-4baa-8941-bfdc28b62b04	1
849431	naproxen sodium 550 MG Oral Tablet	SCD	b91552c0-7de3-4a7a-902b-691eb7ca518b	1
849431	naproxen sodium 550 MG Oral Tablet	SCD	7164427d-38b4-6aae-e053-2995a90a0d07	1
849431	naproxen sodium 550 MG Oral Tablet	SCD	0c01cb34-0d6b-4248-afde-82d4d934dabd	1
849431	naproxen sodium 550 MG Oral Tablet	SCD	30cc16cd-720d-4baa-8941-bfdc28b62b04	1
849431	naproxen sodium 550 MG Oral Tablet	SCD	0fc2f04c-43a0-4831-b499-369f06a4106a	1
849398	naproxen sodium 275 MG (as naproxen 250 MG) Oral Tablet	SY	30cc16cd-720d-4baa-8941-bfdc28b62b04	1
849431	naproxen sodium 550 MG (as naproxen 500 MG) Oral Tablet	SY	b91552c0-7de3-4a7a-902b-691eb7ca518b	1
849431	naproxen sodium 550 MG (as naproxen 500 MG) Oral Tablet	SY	30cc16cd-720d-4baa-8941-bfdc28b62b04	1
849431	naproxen sodium 550 MG (as naproxen 500 MG) Oral Tablet	SY	7164427d-38b4-6aae-e053-2995a90a0d07	1
849431	naproxen sodium 550 MG (as naproxen 500 MG) Oral Tablet	SY	0fc2f04c-43a0-4831-b499-369f06a4106a	1
849431	naproxen sodium 550 MG (as naproxen 500 MG) Oral Tablet	SY	0c01cb34-0d6b-4248-afde-82d4d934dabd	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53746-194-01	53746019401	100 TABLET in 1 BOTTLE (53746-194-01)	100 tablet	2007-04-26	0000-00-00	No	No	Current
53746-194-05	53746019405	500 TABLET in 1 BOTTLE (53746-194-05)	500 tablet	2007-04-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naproxen Sodium	PD-Rx Pharmaceuticals, Inc.	2025-09-15	HUMAN PRESCRIPTION DRUG LABEL	28
Naproxen Sodium	Amneal Pharmaceuticals of New York LLC \| Amneal Pharmaceuticals of New York, LLC	2025-06-05	HUMAN PRESCRIPTION DRUG LABEL	27
NAPROXEN SODIUM	AvKARE	2024-01-09	HUMAN PRESCRIPTION DRUG LABEL	7
Naproxen Sodium	AvPAK	2024-01-04	HUMAN PRESCRIPTION DRUG LABEL	8
Naproxen Sodium	REMEDYREPACK INC.	2023-02-17	HUMAN PRESCRIPTION DRUG LABEL	8
Naproxen Sodium	Bryant Ranch Prepack	2021-12-21	HUMAN PRESCRIPTION DRUG LABEL	5
NAPROXEN SODIUM	DIRECT RX	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	3
Naproxen Sodium Tablets, USP Rx only	NuCare Pharmaceuticals, Inc.	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	2
Naproxen Sodium	AvKARE, Inc.	2020-01-17	HUMAN PRESCRIPTION DRUG LABEL	8
Naproxen Sodium Tablets, USP 275 mg and 550 mg	Proficient Rx LP	2019-12-01	HUMAN PRESCRIPTION DRUG LABEL	2
Naproxen Sodium	Medsource Pharmaceuticals	2018-07-19	HUMAN PRESCRIPTION DRUG LABEL	1
Naproxen Sodium Tablets, USP Rx only	Atlantic Biologicals Corps	2015-11-09	HUMAN PRESCRIPTION DRUG LABEL	3
Naproxen Sodium Tablets, USP 275 mg and 550 mg	RxChange Co.	2014-11-12	HUMAN PRESCRIPTION DRUG LABEL	2
Naproxen Sodium 550MG	Northwind Pharmaceuticals, LLC	2014-08-20	HUMAN PRESCRIPTION DRUG LABEL	1
Naproxen Sodium Tablets, USP 275 mg and 550 mg	Aidarex Pharmaceuticals LLC	2014-01-17	HUMAN PRESCRIPTION DRUG LABEL	1
Naproxen Sodium Tablets, USP 275 mg and 550 mg	State of Florida DOH Central Pharmacy	2013-09-26	HUMAN PRESCRIPTION DRUG LABEL	1
Naproxen Sodium Tablets, USP 275 mg and 550 mg	Rebel Distributors Corp	2011-01-03	HUMAN PRESCRIPTION DRUG LABEL	1
Naproxen Sodium Tablets	Keltman Pharmaceuticals Inc.	2010-12-10	HUMAN PRESCRIPTION DRUG LABEL	1