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 44.

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 · 120 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
2026-10-15 13:18:30	2026-09	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A212517-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A212517-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A212517-003	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A212517-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212517-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A212517-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212517-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212517-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A212517-003	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

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 2 of 2 · 40 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Naproxen	NAPROXEN	PHOENIX RX LLC	43912294-77c9-eda8-e063-6394a90adf0a	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	A-S Medication Solutions	8c3398bd-66b1-4a14-8aaa-e4a2d6749a08	2025-11-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Medcore LLC	129392c8-8ce1-4b78-8863-042db880095f	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	A-S Medication Solutions	cfa88511-40bb-4658-b606-44c68d0746b7	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	A-S Medication Solutions	b500bdba-946a-41ff-855c-1f2937547d01	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Proficient Rx LP	e64b3b36-f96e-463e-aca8-8f6e86724bcf	2025-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	A-S Medication Solutions	7fef9311-471b-472c-b4f2-c952a2b3a255	2025-05-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517 ndc (product): 50090-5645
Naproxen	NAPROXEN	Asclemed USA, Inc.	1e406e47-408a-48cc-921e-52882a11581c	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Direct_Rx	f499a207-02c8-a338-e053-2995a90accc0	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Advanced Rx Pharmacy of Tennessee, LLC	d292f376-1844-b01c-e053-2a95a90a0927	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Quality Care Products, LLC	1acfb8cc-6faf-4b3e-9304-4819c42de0a6	2024-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Advanced Rx Pharmacy of Tennessee, LLC	1431b769-5535-78d6-e063-6394a90a8423	2024-03-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Asclemed USA, Inc.	5a48c0d4-37bf-4c26-a9a7-5c67ff2adb4b	2024-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Medsource Pharmaceuticals	12648efc-3be8-a915-e063-6394a90a3620	2024-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Bryant Ranch Prepack	1cdcaba5-5550-40f6-94cc-b0a98cc17d3c	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Bryant Ranch Prepack	d564f52d-171c-4e7d-974c-3a0e192e6c12	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Proficient Rx LP	d0670241-f1f9-4fdf-83d4-547e7b800811	2022-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Aphena Pharma Solutions - Tennessee, LLC	98efdeb8-ea38-456e-953f-ba589727f284	2021-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Aphena Pharma Solutions - Tennessee, LLC	9c963e77-6e05-47d0-a8d3-e581777377b9	2021-08-19	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