up and up naproxen sodium

Product NDC: 11673-368
11-digit product format: 116730368
Labeler code: 11673
Product ID: 11673-368_25a249be-b52a-4d7e-8352-8e6d30f3664f
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Target Corporation
Application: ANDA074661
Marketing category: ANDA
Marketing start: 2009-06-24
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

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded package	package	11673-368	11673-368-76	D	Discontinued by firm	2026-08-11
excluded package	package	11673-368	11673-368-78	D	Discontinued by firm	2026-08-11
excluded package	package	11673-368	11673-368-82	D	Discontinued by firm	2026-08-11
excluded package	package	11673-368	11673-368-87	D	Discontinued by firm	2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 28 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	11673-368-87	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	11673-368-76	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	11673-368-78	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	11673-368-82	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	11673-368-87	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	11673-368-82	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	11673-368-76	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	11673-368-78	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	11673-368-76	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	11673-368-78	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	11673-368-76	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	11673-368-78	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	11673-368-76	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	11673-368-78	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	11673-368-76	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	11673-368-78	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	11673-368-76	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	11673-368-78	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	11673-368-76	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	11673-368-78	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	11673-368-76	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	11673-368-78	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	11673-368-78	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	11673-368-76	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	11673-368-78	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	11673-368-76	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	11673-368-78	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	11673-368-76	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A074661-001	NAPROXEN SODIUM	NAPROXEN SODIUM	220MG	TABLET / ORAL			1997-01-13

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	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074661-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	1997-01-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074661-001	NAPROXEN SODIUM	EQ 200MG BASE	TABLET / ORAL	1997-01-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074661-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	1997-01-13	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: up and up 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
00bd8490-f280-4336-b13d-0e11c0bf4586	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
11673-368-71	up and up naproxen sodium	1 in 1 CARTON	TABLET, FILM COATED	1	11
11673-368-71	up and up naproxen sodium	50 in 1 BOTTLE	TABLET, FILM COATED	50	11
11673-368-76	up and up naproxen sodium	1 in 1 CARTON	TABLET, FILM COATED	1	11
11673-368-76	up and up naproxen sodium	120 in 1 BOTTLE	TABLET, FILM COATED	120	11
11673-368-78	up and up naproxen sodium	1 in 1 CARTON	TABLET, FILM COATED	1	11
11673-368-78	up and up naproxen sodium	100 in 1 BOTTLE	TABLET, FILM COATED	100	11
11673-368-82	up and up naproxen sodium	200 in 1 BOTTLE	TABLET, FILM COATED	200	11
11673-368-82	up and up naproxen sodium	1 in 1 CARTON	TABLET, FILM COATED	1	11
11673-368-87	up and up naproxen sodium	300 in 1 BOTTLE	TABLET, FILM COATED	300	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
11673-368-71	EA - Each	11673-368	e4add1d5-bd3e-4015-b17a-99f24f07357d	1	2012-07-24
11673-368-78	EA - Each	11673-368	4206d8e2-6c59-4264-97fc-777625e9a839	1	2012-07-24
11673-368-82	EA - Each	11673-368	cf94fe9c-0142-4c38-b7f4-51a7ef436f35	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPROXEN SODIUM	ACTIVE INGREDIENT	9TN87S3A3C	UP AND UP NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [TARGET CORPORATION]	5
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	UP AND UP NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [TARGET CORPORATION]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	UP AND UP NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [TARGET CORPORATION]	5
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	UP AND UP NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [TARGET CORPORATION]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	UP AND UP NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [TARGET CORPORATION]	5
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	UP AND UP NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [TARGET CORPORATION]	5
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	UP AND UP NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [TARGET CORPORATION]	5
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	UP AND UP NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [TARGET CORPORATION]	5
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	UP AND UP NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [TARGET CORPORATION]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
11673-368	UP AND UP NAPROXEN SODIUM (NAPROXEN SODIUM) TABLET, FILM COATED [TARGET CORPORATION]	10	Current NDC, Legacy NDC, 9 package rows	20250101_00bd8490-f280-4336-b13d-0e11c0bf4586.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 3 · 56 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Sense Naproxen Sodium	NAPROXEN SODIUM	Preferred Pharmaceuticals Inc.	2183df53-ac90-4d43-8a5d-8421036bc4cb	2026-07-28	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Naproxen Sodium	NAPROXEN SODIUM	PD-Rx Pharmaceuticals, Inc.	d2b1eedb-2be0-42af-ba0b-9da98560c91e	2026-07-24	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
naproxen sodium	NAPROXEN SODIUM	H E B	b5dcf3df-2628-49c7-9d96-64886bebe631	2026-07-13	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Naproxen Sodium	NAPROXEN SODIUM	PD-Rx Pharmaceuticals, Inc.	c5146d73-2f34-4dfe-ac29-97071279dc4d	2026-05-26	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Berkley and Jensen Naproxen Sodium	NAPROXEN SODIUM	BJWC	9530b649-3e01-452c-99a6-cff47fa4085b	2026-05-21	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Good Sense Naproxen Sodium	NAPROXEN SODIUM	L. Perrigo Company	8e150c00-8e5b-40b4-a964-cb70442c2752	2026-05-11	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
equaline naproxen sodium	NAPROXEN SODIUM	United Natural Foods, Inc. dba UNFI	89c02e55-fa08-4001-96fc-8a01e7e74d5a	2026-05-06	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
all day relief	NAPROXEN SODIUM	Publix Super Markets Inc	0f8843be-50a3-442c-9016-d9da3b444f60	2026-05-06	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
rugby all day relief	NAPROXEN SODIUM	Rugby Laboratories	f587a428-291c-4c54-80fe-244a961b0521	2026-05-06	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Naproxen Sodium	NAPROXEN SODIUM	CVS Pharmacy	efe4352f-856b-4ada-8bd4-0a78423447dc	2026-02-27	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Topcare All Day Pain Relief	NAPROXEN SODIUM	Topco Associates LLC	7f1cda40-9a67-4de1-af56-ab881c6354c4	2026-02-11	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
naproxen sodium	NAPROXEN SODIUM	H E B	2f9439bb-e808-4c54-ba61-f75f117c8b37	2026-02-11	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Naproxen Sodium	NAPROXEN SODIUM	Padagis Israel Pharmaceuticals Ltd	cdb60f74-ce23-4015-90eb-b23a2275f6cb	2026-02-11	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
topcare back and muscle pain	NAPROXEN SODIUM	Topco Associates LLC	de587e8f-38f2-4e7a-8e6a-64e48f280c4f	2026-02-07	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Naproxen Sodium	NAPROXEN SODIUM	Meijer Distribution Inc	db87d1da-8507-4bbf-aefc-3dbd48cde26b	2026-02-05	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Rugby All Day Relief	NAPROXEN SODIUM	Bryant Ranch Prepack	3238dfdc-82d1-4afb-b27c-0ba0a5d24744	2026-02-04	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Good Sense Naproxen Sodium	NAPROXEN SODIUM	L. Perrigo Company	6bc74cda-458c-480e-a33c-d2ba68d5e6bd	2026-01-29	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Care One Naproxen Sodium	NAPROXEN SODIUM	American Sales Company	bc5ddcf2-640c-4683-a60f-ca1c8b418873	2026-01-29	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
Leader All Day Pain Relief	NAPROXEN SODIUM	Cardinal Health 110, LLC. dba Leader	dbf007f5-c792-43a7-8cc1-bfa617f3a7fa	2026-01-26	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661
naproxen sodium	NAPROXEN SODIUM	Meijer Distribution Inc	f4e57560-ae89-4fc3-a66b-ebf3dc3f2448	2026-01-22	Warnings	Exact identifier application applno (ANDA): 074661 application number: ANDA074661

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	00bd8490-f280-4336-b13d-0e11c0bf4586	11
849574	naproxen sodium 220 MG Oral Tablet	SCD	00bd8490-f280-4336-b13d-0e11c0bf4586	11
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	00bd8490-f280-4336-b13d-0e11c0bf4586	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
11673-368-71	11673036871	1 BOTTLE in 1 CARTON (11673-368-71) / 50 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2009-07-14	0000-00-00	No	No	Current
11673-368-76	11673036876	1 BOTTLE in 1 CARTON (11673-368-76) > 120 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2011-11-17	0000-00-00	No	No	Current
11673-368-78	11673036878	1 BOTTLE in 1 CARTON (11673-368-78) > 100 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2009-06-24	0000-00-00	No	No	Current
11673-368-82	11673036882	1 BOTTLE in 1 CARTON (11673-368-82) > 200 TABLET, FILM COATED in 1 BOTTLE	1 bottle	2009-06-24	0000-00-00	No	No	Current
11673-368-87	11673036887	300 TABLET, FILM COATED in 1 BOTTLE (11673-368-87)		2010-03-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Target Corporation Naproxen Sodium Drug Facts	Target Corporation	2025-11-04	HUMAN OTC DRUG LABEL	11