Naproxen Sodium

Product NDC: 68196-255
11-digit product format: 681960255
Labeler code: 68196
Product ID: 68196-255_8f4b0483-1a09-88f8-d289-faed40edd37c
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET, COATED
Route: ORAL
Labeler: SAM'S WEST INC
Application: ANDA075168
Marketing category: ANDA
Marketing start: 1998-07-29
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: 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075168-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			1998-07-28

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075168-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	1998-07-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075168-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	1998-07-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075168-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1998-07-28	`cb3db0bc1861…`

Additional Listing Data#

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

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
7a87a339-4482-ec9e-3c77-7ccb9cea2c4c	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	Strength	SPL version
68196-255-20	Naproxen Sodium	400 in 1 BOTTLE	TABLET, COATED	400		4
68196-255-40	Naproxen Sodium	400 in 1 BOTTLE	TABLET, COATED	400		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68196-255	NAPROXEN SODIUM TABLET, COATED [SAM'S WEST INC]	3	Current NDC, Legacy NDC, 2 package rows	20250308_7a87a339-4482-ec9e-3c77-7ccb9cea2c4c.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen Sodium Caplets	NAPROXEN SODIUM	Dr Reddy's Laboratories Inc	ee0463bc-e939-1ecf-5a86-d045c426fecf	2025-07-22	Warnings	Exact identifier application applno (ANDA): 075168 application number: ANDA075168
Naproxen Sodium Headache Pain Caplets	NAPROXEN SODIUM	Dr.Reddy's Laboratories Inc	605ca130-88aa-27d5-330c-6d9c95987f1f	2025-07-22	Warnings	Exact identifier application applno (ANDA): 075168 application number: ANDA075168
Naproxen Sodium	NAPROXEN SODIUM	SAM'S WEST INC	7a87a339-4482-ec9e-3c77-7ccb9cea2c4c	2025-07-22	Warnings	Exact identifier application applno (ANDA): 075168 application number: ANDA075168 ndc (product): 68196-255
Naproxen Sodium	NAPROXEN SODIUM	Kroger Company	30bcf289-0039-f389-73c4-fef3e8861034	2025-07-22	Warnings	Exact identifier application applno (ANDA): 075168 application number: ANDA075168
Naproxen Sodium	NAPROXEN SODIUM	Dr.Reddy's Laboratories Limited	aca5d497-fbc6-464d-2dee-25c50e11bc78	2025-06-03	Warnings	Exact identifier application applno (ANDA): 075168 application number: ANDA075168
Naproxen Sodium Headache Pain	NAPROXEN SODIUM	Dr.Reddy's Laboratories Inc	12e45b43-eca2-73f4-1d68-07d4238f8c70	2025-06-03	Warnings	Exact identifier application applno (ANDA): 075168 application number: ANDA075168

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	7a87a339-4482-ec9e-3c77-7ccb9cea2c4c	4
849574	naproxen sodium 220 MG Oral Tablet	SCD	7a87a339-4482-ec9e-3c77-7ccb9cea2c4c	4
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	7a87a339-4482-ec9e-3c77-7ccb9cea2c4c	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68196-255-20	68196025520	400 TABLET, COATED in 1 BOTTLE (68196-255-20)	2023-03-01	No	No	Current
68196-255-40	68196025540	400 TABLET, COATED in 1 BOTTLE (68196-255-40)	2025-05-01	No	No	Current