Naproxen Sodium

Product NDC: 36800-748
Requested package NDC: 36800-748-40
11-digit product format: 368000748
Labeler code: 36800
Product ID: 36800-748_5d2ee41d-5c65-4291-a545-019ed68950c5
Type: HUMAN OTC DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: TOP CARE (Topco Associates LLC)
Application: ANDA208363
Marketing category: ANDA
Marketing start: 2018-04-01
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	36800-748	36800-748-40	D	Discontinued by firm		2026-08-03

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
A208363-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL			2018-03-15

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	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208363-001	NAPROXEN SODIUM	EQ 200MG BASE	CAPSULE / ORAL	2018-03-15	`cb3db0bc1861…`

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-748	NAPROXEN SODIUM CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]	7	Legacy NDC	20250502_e4696104-e701-4886-9932-e8eca02278eb.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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen Sodium	NAPROXEN SODIUM	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	c28c4fd2-1428-421c-b62f-265e472d833e	2026-07-09	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	CVS Pharmacy	c194124b-a5f6-423e-bc9a-7b611df990a8	2026-05-13	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Walgreens	d9806ad8-1cea-4599-97ef-a956ec7f0e21	2026-03-11	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Safeway, Inc.	deb1be0f-64ae-46b5-b54a-1a58eec6492e	2026-01-05	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	P & L Development, LLC	fc65fe79-c93b-4247-b9af-e562792a3e64	2025-08-19	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	AAFES/Your Military Exchanges	c387f7cb-7cc4-4989-9f9a-bb00a895fd0d	2025-05-08	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Productos Zapotol Corp.	6386f6f6-9bc7-4b85-ac87-03fd14725904	2024-03-14	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Productos Zapotol Corp.	0a69f39e-5eb6-4a98-85f0-87e7449672d6	2024-03-14	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Care One (Retail Business Services, LLC.)	5582d6e1-4937-43f6-a92c-9d5f9ef1a3ad	2024-02-21	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
All Day Relief	NAPROXEN SODIUM	Publix Supermarkets, Inc.	4db86c5b-62bb-4638-9f1e-98dc2680d6cc	2024-01-23	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	TARGET Corporation	36ce5cd9-8c61-4ed9-b840-c29ad98bdfc5	2023-10-25	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Strategic Sourcing Services LLC	435e55b2-3d75-4a1e-9f00-69b29baf37af	2023-10-02	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Care One (American Sales Company)	043f7032-4e83-4642-93a8-6c09de26b43f	2022-11-21	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Strategic Sourcing Services LLC	a636037d-127c-478d-9d61-dda6eafd2e81	2022-11-15	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
Naproxen Sodium	NAPROXEN SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	de03311d-fb58-43f5-a110-aac9a39c9132	2022-11-07	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
NAPROXEN SODIUM	NAPROXEN SODIUM	PuraCap Pharmaceutical LLC	fc865e81-164c-48e9-8fb9-6fc27d1c33cf	2019-12-10	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363
NAPROXEN SODIUM	NAPROXEN SODIUM	Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd	1d5981dd-e3f5-48a3-a5f1-ce49689cdfac	2019-11-08	Warnings	Exact identifier application applno (ANDA): 208363 application number: ANDA208363

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9TN87S3A3C	NAPROXEN SODIUM	26159-34-2	NAPROXEN SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-748-40	36800074840	1 BOTTLE, PLASTIC in 1 BOX (36800-748-40) > 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC	2018-04-01	0000-00-00	No	No	Current