Naproxen Sodium 220mg

Product NDC: 53329-688
11-digit product format: 533290688
Labeler code: 53329
Product ID: 53329-688_e9d34869-ede4-2a14-e053-2995a90a61fd
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Medline Industries, LP
Application: ANDA090545
Marketing category: ANDA
Marketing start: 2018-08-01
Marketing end: 0000-00-00
Substance: NAPROXEN SODIUM
Active strength: 220 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: 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53329-688		D	Discontinued by firm		2026-10-05
excluded package	package	53329-688	53329-688-30	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090545-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			2011-03-16

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 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090545-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2011-03-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090545-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2011-03-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`f41ea6bd6efb…`

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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53329-688-30	Naproxen Sodium 220mg	100 in 1 BOTTLE	TABLET	100		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-688	NAPROXEN SODIUM 220MG (NAPROXEN SODIUM) TABLET [MEDLINE INDUSTRIES, LP]	7	Legacy NDC, 1 package rows	20241207_6d9b3581-63b5-699e-e053-2991aa0a68f8.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 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen Sodium 220mg	NAPROXEN SODIUM 220MG	Athlete's Needs, Inc.	84445187-8e57-4c0e-83c0-16b105a1cdd2	2018-12-12	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
Naproxen Caplets All day relief for pain	NAPROXEN SODIUM 220 MG	Allegiant Health	81ab5ec4-23c5-44da-b6c8-62f3d3077d48	2018-11-07	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545

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
849574	naproxen sodium 220 MG Oral Tablet	PSN	6d9b3581-63b5-699e-e053-2991aa0a68f8	7
849574	naproxen sodium 220 MG Oral Tablet	SCD	6d9b3581-63b5-699e-e053-2991aa0a68f8	7
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	6d9b3581-63b5-699e-e053-2991aa0a68f8	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-688-30	53329068830	100 TABLET in 1 BOTTLE (53329-688-30)	100 tablet	2018-08-01	0000-00-00	No	No	Current