NAPROXEN

Product NDC: 45865-581
Requested package NDC: 45865-581-90
11-digit product format: 458650581
Labeler code: 45865
Product ID: 45865-581_7d634e58-bdb2-14b0-e053-2a91aa0a50d9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NAPROXEN
Dosage form: TABLET
Route: ORAL
Labeler: medsource pharmaceuticals
Application: ANDA091416
Marketing category: ANDA
Marketing start: 2016-07-06
Marketing end: 0000-00-00
Substance: NAPROXEN
Active strength: 500 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	45865-581	45865-581-90	I	Inactivated by FDA		2026-08-03

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A091416-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14
A091416-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14
A091416-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A091416-001	AB
A091416-002	AB
A091416-003	AB

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091416-002	NAPROXEN	375MG	TABLET / ORAL	AB	2011-02-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091416-003	NAPROXEN	500MG	TABLET / ORAL	AB	2011-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091416-001	NAPROXEN	250MG	TABLET / ORAL	AB	2011-02-14	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091416-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091416-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091416-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091416-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091416-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091416-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091416-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091416-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091416-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091416-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091416-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091416-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091416-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091416-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091416-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091416-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091416-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091416-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091416-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091416-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091416-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091416-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091416-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091416-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091416-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091416-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091416-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091416-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091416-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091416-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091416-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091416-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091416-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091416-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091416-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091416-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091416-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091416-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091416-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091416-001	AB	1	`8072bd15b7f6…`

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
45865-581-30	2025-01-30	C162847	48780-1	2cef2736-824b-d83d-e063-dadaa90ab31f	7d634e58-bdb1-14b0-e053-2a91aa0a50d9
45865-581-60	2025-01-30	C162847	48780-1	2cef2736-824b-d83d-e063-dadaa90ab31f	7d634e58-bdb1-14b0-e053-2a91aa0a50d9
45865-581-90	2025-01-30	C162847	48780-1	2cef2736-824b-d83d-e063-dadaa90ab31f	7d634e58-bdb1-14b0-e053-2a91aa0a50d9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
45865-581-30	NAPROXEN	30 in 1 BOTTLE, PLASTIC	TABLET	30	1
45865-581-60	NAPROXEN	60 in 1 BOTTLE, PLASTIC	TABLET	60	1
45865-581-90	NAPROXEN	90 in 1 BOTTLE, PLASTIC	TABLET	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-581	NAPROXEN TABLET [MEDSOURCE PHARMACEUTICALS]	1	Legacy NDC, 3 package rows	20181220_7d634e58-bdb1-14b0-e053-2a91aa0a50d9.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NAPROXEN	NAPROXEN	Northwind Health Company, LLC	f32d755e-4984-ee40-e053-2995a90a4ebe	2026-01-01	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	QPharma Inc	c0a4839b-7154-c82c-e053-2a95a90a7e6d	2025-12-03	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	PD-Rx Pharmaceuticals, Inc.	a9f9ce81-9d51-4167-9581-974866a8fe31	2025-10-17	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	DIRECT RX	b1b78c49-82e9-2402-e053-2a95a90ae35f	2025-01-17	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
Naproxen	NAPROXEN	Advanced Rx of Tennessee, LLC	af9a96cf-1cda-8ace-e053-2a95a90a18cc	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
Naproxen	NAPROXEN	MARKSANS PHARMA LIMITED	1fdb4cbd-e9e8-47bb-b3d8-1f1ec8f411c8	2024-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	NuCare Pharmaceuticals,Inc.	5487dee2-5c37-4348-e054-00144ff8d46c	2024-07-17	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	NuCare Pharmaceuticals,Inc.	71d4a048-ca50-73db-e053-2a95a90ad465	2024-06-10	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	NuCare Pharmaceuticals,Inc.	69366b55-2687-17a4-e053-2a91aa0a65b3	2024-06-07		Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	Asclemed USA, Inc.	a4fcb411-c918-459b-adc6-06dfa8ed8a50	2022-10-12	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	Aphena Pharma Solutions - Tennessee, LLC	32693390-763b-46dd-b821-65a7bf3c6671	2021-04-26	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	Bryant Ranch Prepack	5d399bf3-db49-411a-91b9-b410d702a65a	2020-12-14	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416
NAPROXEN	NAPROXEN	TIME CAP LABORATORIES	4350a2d9-5228-460e-b7b1-27e8fa846787	2018-10-09	Warnings	Exact identifier application applno (ANDA): 091416 application number: ANDA091416

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
57Y76R9ATQ	NAPROXEN	22204-53-1	NAPROXEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198014	naproxen 500 MG Oral Tablet	PSN	7d634e58-bdb1-14b0-e053-2a91aa0a50d9	1
198014	naproxen 500 MG Oral Tablet	SCD	7d634e58-bdb1-14b0-e053-2a91aa0a50d9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-581-90	45865058190	90 TABLET in 1 BOTTLE, PLASTIC (45865-581-90)	90 tablet	2018-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NAPROXEN - medsource pharmaceuticals \| TIME CAP LABORATORIES	medsource pharmaceuticals \| TIME CAP LABORATORIES	2018-12-19	HUMAN PRESCRIPTION DRUG LABEL	1