Naproxen

Product NDC: 50090-5645
11-digit product format: 500905645
Labeler code: 50090
Product ID: 50090-5645_35a43392-eb57-4493-be32-5c7e74b2fdd7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA212517
Marketing category: ANDA
Marketing start: 2020-03-01
Substance: NAPROXEN
Active strength: 500 mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 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
A212517-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21
A212517-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21
A212517-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212517-001	AB
A212517-002	AB
A212517-003	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 3 · 111 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	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 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	A212517-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212517-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212517-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212517-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212517-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212517-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212517-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212517-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212517-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212517-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212517-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212517-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212517-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212517-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212517-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212517-001	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	500 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
7fef9311-471b-472c-b4f2-c952a2b3a255	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, Related label table
NDC	Effective	Related label
50090-5645-0	2023-02-07	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
50090-5645-1	2023-02-07	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
50090-5645-2	2023-02-07	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
50090-5645-4	2023-02-07	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
50090-5645-5	2023-02-07	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
50090-5645-6	2023-02-07	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
50090-5645-7	2023-02-07	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
50090-5645-9	2023-02-07	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
50090-5645-0	2023-01-30	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
50090-5645-1	2023-01-30	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
50090-5645-2	2023-01-30	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
50090-5645-4	2023-01-30	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
50090-5645-5	2023-01-30	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
50090-5645-6	2023-01-30	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
50090-5645-7	2023-01-30	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
50090-5645-9	2023-01-30	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
50090-5645-0	Naproxen	15 in 1 BOTTLE	TABLET	15	5
50090-5645-1	Naproxen	20 in 1 BOTTLE	TABLET	20	5
50090-5645-2	Naproxen	30 in 1 BOTTLE	TABLET	30	5
50090-5645-4	Naproxen	14 in 1 BOTTLE	TABLET	14	5
50090-5645-5	Naproxen	40 in 1 BOTTLE	TABLET	40	5
50090-5645-6	Naproxen	100 in 1 BOTTLE	TABLET	100	5
50090-5645-7	Naproxen	60 in 1 BOTTLE	TABLET	60	5
50090-5645-9	Naproxen	6 in 1 BOTTLE	TABLET	6	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5645-0	EA - Each	50090-5645	16403720-0235-497a-833b-008844f373a5	1	2022-10-06
50090-5645-1	EA - Each	50090-5645	128621c4-79c0-4b29-a7d8-0aa31613d6a5	1	2022-10-06
50090-5645-2	EA - Each	50090-5645	2e2fc428-7a46-4686-a385-abe42164d89a	1	2022-10-06
50090-5645-4	EA - Each	50090-5645	3ff92097-207b-4d42-951b-367e1ce01f8d	1	2022-10-06
50090-5645-5	EA - Each	50090-5645	633f850f-cb02-427f-b212-31db5f3e3a77	1	2022-10-06
50090-5645-6	EA - Each	50090-5645	a3a9d694-866b-43e3-ada8-f86a2edce81e	1	2022-10-06
50090-5645-7	EA - Each	50090-5645	b5f25e7e-51a5-4fc2-b439-fd82681e3e93	1	2022-10-06
50090-5645-9	EA - Each	50090-5645	62bf25b6-dc9a-4aca-a669-e9ffd9182a37	1	2022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5645	NAPROXEN TABLET [A-S MEDICATION SOLUTIONS]	5	Current NDC, Legacy NDC, 8 package rows	20250508_7fef9311-471b-472c-b4f2-c952a2b3a255.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 2 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	PD-Rx Pharmaceuticals, Inc.	24d44eb6-921e-4150-a6b2-81f42ced32ab	2026-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Preferred Pharmaceuticals Inc.	49a00870-f580-4eb9-a95d-48fa956f147f	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Preferred Pharmaceuticals, Inc.	9f026fd5-f996-4383-b528-841d38d3dab5	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	HAWAII REPACK, INC.	888efc91-b4de-4691-b84c-fb871e7a6dfe	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	St. Mary's Medical Park Pharmacy	e3a3e5d2-2d1e-74d3-e053-2995a90a82bf	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	REMEDYREPACK INC.	ccd95dfc-9236-4707-a715-6a12c91519ff	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	ST. MARY'S MEDICAL PARK PHARMACY	e3a4ab4a-b109-eb5e-e053-2a95a90afddd	2026-06-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Bryant Ranch Prepack	2e72de28-e62b-44e0-b17d-500d13e0bcc6	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Bryant Ranch Prepack	bbc61c0a-491a-4f50-a7bf-2ca94c771568	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Sportpharm LLC	1c5b2bc1-26bb-4f88-bded-399263c82331	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Bryant Ranch Prepack	f18181f4-6b14-48a8-a149-e45b3360a250	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Bryant Ranch Prepack	97d6c4ef-13b1-4b0b-a15a-f0590019940d	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Bryant Ranch Prepack	852fed15-e78b-47a8-aeb4-623dfe1edad9	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	REMEDYREPACK INC.	6bb65680-76ea-46e5-ae70-f3091e360368	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Radha Pharmaceuticals, Inc.	1a2b9a82-5b79-45ee-94ed-7a6f8c8b5170	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	ScieGen Pharmaceuticals, Inc.	81e22c1f-f94d-46e9-8b7d-72dc2518319e	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	NuCare Pharmaceuticals,Inc.	c136cf75-4ad4-8634-e053-2a95a90a53a4	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	PD-Rx Pharmaceuticals, Inc.	fa2fe6fd-c476-dd29-e053-6294a90a9e9e	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Northwind Health Company, LLC	db478961-d984-7c8e-e053-2995a90a8a12	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Northwind Health Company, LLC	c986ba9a-6f48-8347-e053-2a95a90aa1c1	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517

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
198014	naproxen 500 MG Oral Tablet	PSN	7fef9311-471b-472c-b4f2-c952a2b3a255	5
198014	naproxen 500 MG Oral Tablet	SCD	7fef9311-471b-472c-b4f2-c952a2b3a255	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5645-0	50090564500	15 TABLET in 1 BOTTLE (50090-5645-0)	15 tablet	2021-09-13	0000-00-00	No	No	Current
50090-5645-1	50090564501	20 TABLET in 1 BOTTLE (50090-5645-1)	20 tablet	2021-09-13	0000-00-00	No	No	Current
50090-5645-2	50090564502	30 TABLET in 1 BOTTLE (50090-5645-2)	30 tablet	2021-09-13	0000-00-00	No	No	Current
50090-5645-4	50090564504	14 TABLET in 1 BOTTLE (50090-5645-4)	14 tablet	2021-09-13	0000-00-00	No	No	Current
50090-5645-5	50090564505	40 TABLET in 1 BOTTLE (50090-5645-5)	40 tablet	2021-09-13	0000-00-00	No	No	Current
50090-5645-6	50090564506	100 TABLET in 1 BOTTLE (50090-5645-6)	100 tablet	2021-09-13	0000-00-00	No	No	Current
50090-5645-7	50090564507	60 TABLET in 1 BOTTLE (50090-5645-7)	60 tablet	2021-09-13	0000-00-00	No	No	Current
50090-5645-9	50090564509	6 TABLET in 1 BOTTLE (50090-5645-9)	6 tablet	2021-09-13	0000-00-00	No	No	Current