NAPROXEN SODIUM

Product NDC: 49483-609
Requested package NDC: 49483-609-01
11-digit product format: 494830609
Labeler code: 49483
Product ID: 49483-609_cbf198fe-25e4-694c-e053-2995a90aae22
Type: HUMAN OTC DRUG
Nonproprietary name: NAPROXEN SODIUM
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: TIME CAP LABORATORIES, INC
Application: ANDA090545
Marketing category: ANDA
Marketing start: 2016-03-28
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

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	49483-609	49483-609-01	I	Inactivated by FDA		excluded / ndc_excluded.zip	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	49483-609	49483-609-01	I	Inactivated by FDA		excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`

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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090545-001	NAPROXEN SODIUM	220MG	TABLET / ORAL	2011-03-16	`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
17ecaee0-c1c6-4360-81c1-d6afe50b9b27	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49483-609-00	2020-01-31	C162847	48780-1	9d75b9cf-f3f8-f424-e053-dadaa90a57ce	609R 49483-609 Naproxen Sodium Tablets 220 mg
49483-609-01	2020-01-31	C162847	48780-1	9d75b9cf-f3f8-f424-e053-dadaa90a57ce	609R 49483-609 Naproxen Sodium Tablets 220 mg
49483-609-05	2020-01-31	C162847	48780-1	9d75b9cf-f3f8-f424-e053-dadaa90a57ce	609R 49483-609 Naproxen Sodium Tablets 220 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49483-609-00	NAPROXEN SODIUM	6500 in 1 BAG	TABLET, FILM COATED	6500	4
49483-609-01	NAPROXEN SODIUM	100 in 1 BOTTLE	TABLET, FILM COATED	100	4
49483-609-05	NAPROXEN SODIUM	50 in 1 BOTTLE	TABLET, FILM COATED	50	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49483-609-01	EA - Each	49483-609	aec58f53-f7c6-464f-b7c3-708677ccfcc6	1	2016-10-06
49483-609-05	EA - Each	49483-609	03571167-6eb8-4075-a128-b770ed69ac1d	1	2016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49483-609	NAPROXEN SODIUM TABLET, FILM COATED [TIME CAP LABORATORIES, INC]	4	Current NDC, Legacy NDC, 3 package rows	20211202_17ecaee0-c1c6-4360-81c1-d6afe50b9b27.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 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	Grocery Outlet	1f5b5c55-44df-4872-8c74-b8a812efc32a	2026-03-18	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
BACK AND MUSCLE PAIN	NAPROXEN	WALGREENS	81417810-8a34-c859-e053-2a91aa0a6507	2026-01-26	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
CALMADOL PAIN RELIEVER	NAPROXEN SODIUM	GRANDALL DISTRIBUTING, LLC	8edec8d1-a323-436b-8329-c327438516e3	2025-10-28	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
Naproxen Sodium	NAPROXEN SODIUM 220MG	CVS Pharmacy, Inc.	1fde52e7-7a7f-40e8-e063-6394a90a922a	2025-08-11	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
All Day Pain Relief	NAPROXEN SODIUM	Walmart Inc.	32df7378-4dd1-4f7e-e063-6394a90ad948	2025-05-09	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
Belmora Flanax	NAPROXEN SODIUM	Belmora LLC	a44b8a82-251d-d5e8-e053-2a95a90a72f7	2024-10-08	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
ALL DAY PAIN RELIEF	NAPROXEN SODIUM	WALGREENS	8771b84f-47bf-116c-e053-2995a90a0aad	2024-03-15	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
ALL DAY PAIN RELIEF	NAPROXEN SODIUM	WALGREENS	8771300f-e907-3d53-e053-2a95a90ae402	2024-03-15	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
All Day Back and Muscle Pain Relief	NAPROXEN SODIUM	Walmart Inc.	062b9ffe-b4fc-9f5a-e063-6294a90a560e	2023-12-04	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
NAPROXEN SODIUM	NAPROXEN SODIUM	TIME CAP LABORATORIES, INC	ab7b7b8e-923b-4dc1-812c-78e85de1bee1	2023-09-13	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
Pain Relief	NAPROXEN SODIUM	BETTER LIVING BRANDS, LLC	eb604ea6-f5c1-156b-e053-2a95a90a76d7	2023-06-13	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
Naproxen Sodium	NAPROXEN SODIUM	BETTER LIVING BRANDS LLC.	f2c06861-0322-93ed-e053-2995a90a5902	2023-06-13	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
Naproxen Sodium	NAPROXEN SODIUM, COATED TABLETS	MARKSANS PHARMA LIMITED	48cb1363-ff12-40ee-a87a-2252dfbf8ff7	2023-06-09	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
Flanax Pain Reliever/Fever Reducer	NAPROXEN SODIUM	Navajo Manufacturing Company Inc.	f706b406-58f2-9b82-e053-6394a90ab598	2023-03-16	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
NAPROXEN SODIUM	NAPROXEN SODIUM	TIME CAP LABORATORIES, INC	17ecaee0-c1c6-4360-81c1-d6afe50b9b27	2021-12-01	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545 ndc (package): 49483-609-01 ndc (product): 49483-609 ndc11 (package): 49483060901
NAPROXEN SODIUM	NAPROXEN SODIUM	Kroger Company	bc185bf2-bc2c-f439-e053-2995a90a93d0	2021-06-03	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
Naproxen Sodium 220mg	NAPROXEN SODIUM 220MG	Allegiant Health	14554f05-14e1-4c52-99ce-94561c42c0da	2021-04-21	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
Flanax Pain Reliever/Fever reducer	NAPROXEN SODIUM	Belmora LLC	05337e0b-8baf-42d6-a642-3052f77ed304	2020-05-29	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
Naproxen Caplets	NAPROXEN SODIUM 220 MG	Allegiant Health	07120764-7c33-4c07-9367-40956d970c60	2019-06-06	Warnings	Exact identifier application applno (ANDA): 090545 application number: ANDA090545
Naproxen Sodium 220mg	NAPROXEN SODIUM 220MG	Command Brands, LLC	002052df-83ac-4efd-926c-b60a8f64cec4	2018-12-14	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	17ecaee0-c1c6-4360-81c1-d6afe50b9b27	4
849574	naproxen sodium 220 MG Oral Tablet	SCD	17ecaee0-c1c6-4360-81c1-d6afe50b9b27	4
849574	naproxen sodium 220 MG (as naproxen 200 MG) Oral Tablet	SY	17ecaee0-c1c6-4360-81c1-d6afe50b9b27	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
49483-609-01	49483060901	100 TABLET, FILM COATED in 1 BOTTLE (49483-609-01)	2016-03-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
609R 49483-609 Naproxen Sodium Tablets 220 mg	TIME CAP LABORATORIES, INC \| MARKSANS PHARMA LIMITED	2021-12-01	HUMAN OTC DRUG LABEL	4