Naproxen

Product NDC: 53746-188
11-digit product format: 537460188
Labeler code: 53746
Product ID: 53746-188_e54d008a-9b47-42fa-a8c1-23dc72527132
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA075927
Marketing category: ANDA
Marketing start: 2010-02-18
Substance: NAPROXEN
Active strength: 250 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	Approval date
A075927-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18
A075927-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18
A075927-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075927-001	AB
A075927-002	AB
A075927-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075927-002	NAPROXEN	375MG	TABLET / ORAL	AB	2001-12-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075927-003	NAPROXEN	500MG	TABLET / ORAL	AB	2001-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075927-001	NAPROXEN	250MG	TABLET / ORAL	AB	2001-12-18	`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	A075927-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075927-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075927-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075927-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075927-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075927-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075927-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075927-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075927-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075927-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075927-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075927-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075927-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075927-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075927-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075927-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075927-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075927-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075927-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075927-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075927-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075927-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075927-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075927-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075927-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075927-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075927-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075927-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075927-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075927-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075927-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075927-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075927-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075927-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075927-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075927-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075927-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075927-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075927-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075927-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPROXEN	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
57Y76R9ATQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198012	Internal RxNorm lookup
198013	Internal RxNorm lookup
198014	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
2718e0b7-1ce6-457e-bee9-11b634dfd353	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
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
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
53746-188-01	2021-02-17	These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53746-188-05	2021-02-17	These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53746-188-10	2021-02-17	These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53746-188-01	2021-01-29	These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53746-188-05	2021-01-29	These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976
53746-188-10	2021-01-29	These highlights do not include all the information needed to use NAPROXEN TABLETS safely and effectively. See full prescribing information for NAPROXEN TABLETS. NAPROXEN tablets, for oral use Initial U.S. Approval: 1976

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53746-188-01	Naproxen	100 in 1 BOTTLE	TABLET	100	27
53746-188-05	Naproxen	500 in 1 BOTTLE	TABLET	500	27
53746-188-10	Naproxen	1000 in 1 BOTTLE	TABLET	1000	27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53746-188-01	EA - Each	53746-188	5d614276-b6a1-4d4c-9782-0fdfc0e450b3	1	2012-07-24
53746-188-05	EA - Each	53746-188	c237854b-d9e7-4005-9f05-72e2e1969766	1	2012-07-24
53746-188-10	EA - Each	53746-188	ce9d6821-d314-4412-bfa7-34785542a3c1	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
.GAMMA.-AMINOBUTYRIC ACID	ACTIVE INGREDIENT	2ACZ6IPC6I	THERAPROXEN-90 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	14
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	THERAPROXEN-90 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	14
.GAMMA.-AMINOBUTYRIC ACID	ACTIVE MOIETY	2ACZ6IPC6I	THERAPROXEN-90 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	14
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	THERAPROXEN-90 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	14
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	THERAPROXEN-90 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	14
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	THERAPROXEN-90 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	14
GELATIN	INACTIVE INGREDIENT	2G86QN327L	THERAPROXEN-90 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	14
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	THERAPROXEN-90 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	14
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	THERAPROXEN-90 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	14
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	THERAPROXEN-90 (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	14
HISTIDINE	ACTIVE INGREDIENT	4QD397987E	TREPOXEN-250 (NAPROXEN,HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]	13
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	TREPOXEN-250 (NAPROXEN,HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]	13
HISTIDINE	ACTIVE MOIETY	4QD397987E	TREPOXEN-250 (NAPROXEN,HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]	13
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	TREPOXEN-250 (NAPROXEN,HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TREPOXEN-250 (NAPROXEN,HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]	13
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	TREPOXEN-250 (NAPROXEN,HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]	13
GELATIN	INACTIVE INGREDIENT	2G86QN327L	TREPOXEN-250 (NAPROXEN,HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]	13
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TREPOXEN-250 (NAPROXEN,HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]	13
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	TREPOXEN-250 (NAPROXEN,HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]	13
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	TREPOXEN-250 (NAPROXEN,HISTIDINE) KIT [PHYSICIAN THERAPEUTICS LLC]	13
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	10
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	10
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	10
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	10
.GAMMA.-AMINOBUTYRIC ACID	ACTIVE INGREDIENT	2ACZ6IPC6I	THERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	7
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	THERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	7
.GAMMA.-AMINOBUTYRIC ACID	ACTIVE MOIETY	2ACZ6IPC6I	THERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	7
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	THERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	7
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	THERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	7
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	THERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	7
FD&C RED NO. 3	INACTIVE INGREDIENT	PN2ZH5LOQY	THERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	7
GELATIN	INACTIVE INGREDIENT	2G86QN327L	THERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	THERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	7
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	THERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	7
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	THERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	THERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	THERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	7
TRICALCIUM PHOSPHATE	INACTIVE INGREDIENT	K4C08XP666	THERAPROXEN (NAPROXEN, .GAMMA.-AMINOBUTYRIC ACID) KIT [PHYSICIAN THERAPEUTICS LLC]	7
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]	3
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN TABLET [REBEL DISTRIBUTORS CORP.]	3
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET [CARILION MATERIALS MANAGEMENT]	2
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET [CARILION MATERIALS MANAGEMENT]	2
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN TABLET [KELTMAN PHARMACEUTICALS INC.]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN TABLET [CARILION MATERIALS MANAGEMENT]	2
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN TABLET [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53746-188	NAPROXEN TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]	27	Current NDC, Legacy NDC, 3 package rows	20250316_2718e0b7-1ce6-457e-bee9-11b634dfd353.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 · 18 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	Preferred Pharmaceuticals Inc.	c5e52ddd-a909-487a-bb46-01ad35690665	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	A-S Medication Solutions	c5c8b6fd-f3f5-4fed-823c-9a80386b27b1	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	AvPAK	e6fbf8f1-b064-658d-17bb-e7d6320aa45f	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	Northwind Health Company, LLC	ab6ec2c9-5df9-346c-e053-2a95a90ac81d	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	QPharma, Inc.	307aa67f-53b9-4c60-a328-091bbf6338d4	2025-12-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	PD-Rx Pharmaceuticals, Inc.	29d98cf3-a0f2-3f89-e054-00144ff88e88	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	PD-Rx Pharmaceuticals, Inc.	6573681e-e9be-440f-a818-a533b744648e	2025-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	Amneal Pharmaceuticals LLC	c43a43e2-e867-448d-8f59-3efc7c077cbc	2025-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	Bryant Ranch Prepack	9d7bc470-fbba-40a6-a56c-f681a3cee9cf	2025-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	Amneal Pharmaceuticals of New York LLC	2718e0b7-1ce6-457e-bee9-11b634dfd353	2025-03-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927 ndc (product): 53746-188
Naproxen	NAPROXEN	Advanced Rx of Tennessee, LLC	af9ad850-57b5-a21d-e053-2a95a90ae68e	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	Advanced Rx of Tennessee, LLC	af9a94a8-3825-eabd-e053-2a95a90acd58	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	Bryant Ranch Prepack	a4f31070-4ee1-4d64-8b1d-40b9011e124b	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	A-S Medication Solutions	80233fa5-f8b4-42d5-a8c9-4a1d8fd4aba4	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	A-S Medication Solutions	21930f73-d3c2-4462-a487-74ed871b74b2	2023-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	A-S Medication Solutions	a5ea3a84-7acd-4f24-9f0f-9f871ce1b5f4	2023-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	Proficient Rx LP	fc3ee94a-adb7-411e-a662-2f2c6ddbabaf	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927
Naproxen	NAPROXEN	NCS HealthCare of KY, Inc dba Vangard Labs	62a12771-bde9-4bc3-9ce9-672c8e31f020	2017-10-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075927 application number: ANDA075927

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
57Y76R9ATQ	NAPROXEN	22204-53-1	NAPROXEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198013	naproxen 250 MG Oral Tablet	PSN	53865075-2d8d-4390-b392-5645cfd90e7b	34
198012	naproxen 375 MG Oral Tablet	PSN	53865075-2d8d-4390-b392-5645cfd90e7b	34
198014	naproxen 500 MG Oral Tablet	PSN	53865075-2d8d-4390-b392-5645cfd90e7b	34
198013	naproxen 250 MG Oral Tablet	SCD	53865075-2d8d-4390-b392-5645cfd90e7b	34
198012	naproxen 375 MG Oral Tablet	SCD	53865075-2d8d-4390-b392-5645cfd90e7b	34
198014	naproxen 500 MG Oral Tablet	SCD	53865075-2d8d-4390-b392-5645cfd90e7b	34
198013	naproxen 250 MG Oral Tablet	PSN	2718e0b7-1ce6-457e-bee9-11b634dfd353	27
198012	naproxen 375 MG Oral Tablet	PSN	2718e0b7-1ce6-457e-bee9-11b634dfd353	27
198014	naproxen 500 MG Oral Tablet	PSN	2718e0b7-1ce6-457e-bee9-11b634dfd353	27
198013	naproxen 250 MG Oral Tablet	SCD	2718e0b7-1ce6-457e-bee9-11b634dfd353	27
198012	naproxen 375 MG Oral Tablet	SCD	2718e0b7-1ce6-457e-bee9-11b634dfd353	27
198014	naproxen 500 MG Oral Tablet	SCD	2718e0b7-1ce6-457e-bee9-11b634dfd353	27
198013	naproxen 250 MG Oral Tablet	PSN	29acd686-ca11-42b0-b5cd-5c1a04e45c29	14
198013	naproxen 250 MG Oral Tablet	SCD	29acd686-ca11-42b0-b5cd-5c1a04e45c29	14
198013	naproxen 250 MG Oral Tablet	PSN	c957df9a-eb66-432f-a280-9cd74389d667	13
198013	naproxen 250 MG Oral Tablet	SCD	c957df9a-eb66-432f-a280-9cd74389d667	13
198013	naproxen 250 MG Oral Tablet	PSN	c3f47985-0027-4fa7-aab2-5bc6ca79a6e8	7
198013	naproxen 250 MG Oral Tablet	SCD	c3f47985-0027-4fa7-aab2-5bc6ca79a6e8	7
198013	naproxen 250 MG Oral Tablet	PSN	9f119b61-24fc-437a-b7b9-ff9939c094d5	3
198013	naproxen 250 MG Oral Tablet	PSN	8c7b265e-7500-464a-854e-9c4a22c8d211	3
198013	naproxen 250 MG Oral Tablet	PSN	92c48cd9-e645-4871-a0ad-9ea56623edb6	3
198012	naproxen 375 MG Oral Tablet	PSN	8c7b265e-7500-464a-854e-9c4a22c8d211	3
198012	naproxen 375 MG Oral Tablet	PSN	92c48cd9-e645-4871-a0ad-9ea56623edb6	3
198014	naproxen 500 MG Oral Tablet	PSN	8c7b265e-7500-464a-854e-9c4a22c8d211	3
198014	naproxen 500 MG Oral Tablet	PSN	92c48cd9-e645-4871-a0ad-9ea56623edb6	3
198013	naproxen 250 MG Oral Tablet	SCD	9f119b61-24fc-437a-b7b9-ff9939c094d5	3
198013	naproxen 250 MG Oral Tablet	SCD	8c7b265e-7500-464a-854e-9c4a22c8d211	3
198013	naproxen 250 MG Oral Tablet	SCD	92c48cd9-e645-4871-a0ad-9ea56623edb6	3
198012	naproxen 375 MG Oral Tablet	SCD	8c7b265e-7500-464a-854e-9c4a22c8d211	3
198012	naproxen 375 MG Oral Tablet	SCD	92c48cd9-e645-4871-a0ad-9ea56623edb6	3
198014	naproxen 500 MG Oral Tablet	SCD	8c7b265e-7500-464a-854e-9c4a22c8d211	3
198014	naproxen 500 MG Oral Tablet	SCD	92c48cd9-e645-4871-a0ad-9ea56623edb6	3
198013	naproxen 250 MG Oral Tablet	PSN	1a10952e-0662-4f2c-bd02-28dd4eee138f	2
198012	naproxen 375 MG Oral Tablet	PSN	1a10952e-0662-4f2c-bd02-28dd4eee138f	2
198014	naproxen 500 MG Oral Tablet	PSN	1a10952e-0662-4f2c-bd02-28dd4eee138f	2
198013	naproxen 250 MG Oral Tablet	SCD	1a10952e-0662-4f2c-bd02-28dd4eee138f	2
198012	naproxen 375 MG Oral Tablet	SCD	1a10952e-0662-4f2c-bd02-28dd4eee138f	2
198014	naproxen 500 MG Oral Tablet	SCD	1a10952e-0662-4f2c-bd02-28dd4eee138f	2
198013	naproxen 250 MG Oral Tablet	PSN	6b10c3ff-7cd9-4a59-9436-d2c6a64e4a69	1
198013	naproxen 250 MG Oral Tablet	PSN	f23569ab-d9ac-45e8-b8f3-8d0ba612fc2d	1
198012	naproxen 375 MG Oral Tablet	PSN	6b10c3ff-7cd9-4a59-9436-d2c6a64e4a69	1
198014	naproxen 500 MG Oral Tablet	PSN	f23569ab-d9ac-45e8-b8f3-8d0ba612fc2d	1
198013	naproxen 250 MG Oral Tablet	SCD	f23569ab-d9ac-45e8-b8f3-8d0ba612fc2d	1
198013	naproxen 250 MG Oral Tablet	SCD	6b10c3ff-7cd9-4a59-9436-d2c6a64e4a69	1
198012	naproxen 375 MG Oral Tablet	SCD	6b10c3ff-7cd9-4a59-9436-d2c6a64e4a69	1
198014	naproxen 500 MG Oral Tablet	SCD	f23569ab-d9ac-45e8-b8f3-8d0ba612fc2d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53746-188-01	53746018801	100 TABLET in 1 BOTTLE (53746-188-01)	100 tablet	2010-02-18	0000-00-00	No	No	Current
53746-188-05	53746018805	500 TABLET in 1 BOTTLE (53746-188-05)	500 tablet	2010-02-18	0000-00-00	No	No	Current
53746-188-10	53746018810	1000 TABLET in 1 BOTTLE (53746-188-10)	1000 tablet	2010-02-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naproxen	Amneal Pharmaceuticals of New York LLC \| Amneal Pharmaceuticals, LLC	2025-03-14	HUMAN PRESCRIPTION DRUG LABEL	27
Naproxen	A-S Medication Solutions	2021-06-10	HUMAN PRESCRIPTION DRUG LABEL	34
Naproxen Tablets, USP	Carilion Materials Management	2016-08-04	HUMAN PRESCRIPTION DRUG LABEL	3
Naproxen Tablets, USP	Aphena Pharma Solutions - Tennessee, LLC	2014-06-09	HUMAN PRESCRIPTION DRUG LABEL	3
Naproxen Tablets, USP	Aidarex Pharmaceuticals LLC	2014-01-17	HUMAN PRESCRIPTION DRUG LABEL	1
Theraproxen-90	Physician Therapeutics LLC \| Amneal Pharmaceuticals \| H.J. Harkins Company, Inc. \| Targeted Medical Pharma Inc.	2011-08-01	HUMAN PRESCRIPTION DRUG LABEL	14
Trepoxen-250	Physician Therapeutics LLC \| Amneal Pharmaceuticals \| H.J. Harkins Company, Inc. \| Targeted Medical Pharma Inc.	2011-08-01	HUMAN PRESCRIPTION DRUG LABEL	13
Theraproxen	Physician Therapeutics LLC \| Amneal Pharmaceuticals \| Targeted Medical Pharma Inc. \| H.J. Harkins Company, Inc	2011-08-01	HUMAN PRESCRIPTION DRUG LABEL	7
Naproxen Tablets, USP	Keltman Pharmaceuticals Inc. \| Sandhills Packaging	2010-10-04	HUMAN PRESCRIPTION DRUG LABEL	2
Naproxen Tablets, USP	State of Florida DOH Central Pharmacy	2010-06-07	HUMAN PRESCRIPTION DRUG LABEL	1
Naproxen Tablets, USP	Rebel Distributors Corp.	2010-02-18	HUMAN PRESCRIPTION DRUG LABEL	3