Naproxen Sodium

Product NDC: 50844-604
11-digit product format: 508440604
Labeler code: 50844
Product ID: 50844-604_89d3ed35-e75c-41d8-aa99-57cc1fd866d2
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: L.N.K. International, Inc.
Application: ANDA204872
Marketing category: ANDA
Marketing start: 2017-02-01
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: 2027-12-31
Current FDA listing: Yes

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
A204872-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			2017-01-23

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	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204872-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2017-01-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204872-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	2017-01-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204872-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2017-01-23	`f41ea6bd6efb…`

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 Sodium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPROXEN SODIUM	220 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9TN87S3A3C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
849574	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
717518e4-2537-4229-b765-c6acfe963d4b	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50844-604-06	Naproxen Sodium	200 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	200	15
50844-604-09	Naproxen Sodium	4 in 1 CARTON	TABLET, FILM COATED	4	15
50844-604-09	Naproxen Sodium	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	15
50844-604-14	Naproxen Sodium	500 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	500	15
50844-604-15	Naproxen Sodium	1 in 1 CARTON	TABLET, FILM COATED	1	15
50844-604-15	Naproxen Sodium	50 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	50	15
50844-604-16	Naproxen Sodium	1000 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	1000	15
50844-604-19	Naproxen Sodium	8 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	8	15
50844-604-19	Naproxen Sodium	1 in 1 CARTON	TABLET, FILM COATED	1	15
50844-604-56	Naproxen Sodium	25 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	25	15
50844-604-98	Naproxen Sodium	8 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	8	15
50844-604-99	Naproxen Sodium	8 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	8	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50844-604	NAPROXEN SODIUM TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.]	13	Current NDC, Legacy NDC, 12 package rows	20250116_717518e4-2537-4229-b765-c6acfe963d4b.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 · 27 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN SODIUM	Family Dollar Services Inc	b6205032-f5c6-494a-8b87-adbbbc3982e7	2025-10-27	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen	NAPROXEN SODIUM	Amerisource Bergen	1e2e6e3a-b095-4d5b-86fe-61eb44a87cf0	2025-10-20	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
First Aid Direct All Day Pain Relief	NAPROXEN SODIUM	Cintas Corporation	1c9384c1-52f8-4482-88fc-5f5b6d770c42	2025-09-22	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen	NAPROXEN SODIUM	Geri-Care Pharmaceutical Corp	9a61d544-e46d-6703-e053-2a95a90a32fd	2025-02-27	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen	NAPROXEN SODIUM	NuCare Pharmaceuticals,Inc.	f1ed8384-83d6-6f2a-e053-2a95a90ab08f	2025-02-04	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen	NAPROXEN SODIUM	Bryant Ranch Prepack	f9ddc614-26b7-48dc-ae93-02da6388f2d5	2025-01-30	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872
Naproxen	NAPROXEN SODIUM	Proficient Rx LP	2acd8e24-449d-4f5c-9323-504013ff4bf5	2023-07-28	Warnings	Exact identifier application applno (ANDA): 204872 application number: ANDA204872

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	717518e4-2537-4229-b765-c6acfe963d4b	15
849574	naproxen sodium 220 MG Oral Tablet	SCD	717518e4-2537-4229-b765-c6acfe963d4b	15
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	717518e4-2537-4229-b765-c6acfe963d4b	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50844-604-06	50844060406	200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-604-06)		2026-02-19		No	No	Current
50844-604-09	50844060409	4 BLISTER PACK in 1 CARTON (50844-604-09) / 5 TABLET, FILM COATED in 1 BLISTER PACK	4 blister pack	2017-02-01	0000-00-00	No	No	Current
50844-604-14	50844060414	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-604-14)		2017-02-01	0000-00-00	No	No	Current
50844-604-15	50844060415	1 BOTTLE, PLASTIC in 1 CARTON (50844-604-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		2017-02-01		No	No	Current
50844-604-16	50844060416	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-604-16)		2017-02-01	0000-00-00	No	No	Current
50844-604-19	50844060419	1 BOTTLE, PLASTIC in 1 CARTON (50844-604-19) / 8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		2017-02-01	0000-00-00	No	No	Current
50844-604-56	50844060456	25 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-604-56)		2017-02-01	0000-00-00	No	No	Current
50844-604-98	50844060498	8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-604-98)		2017-02-01	0000-00-00	No	No	Current
50844-604-99	50844060499	8 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-604-99)		2017-02-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Quality Plus 44-417 and 44-604	L.N.K. International, Inc. \| LNK International, Inc.	2026-02-25	HUMAN OTC DRUG LABEL	15