NAPROXEN

Product NDC: 69543-425
11-digit product format: 695430425
Labeler code: 69543
Product ID: 69543-425_2c77658c-b5b6-4d22-a218-1334a0d13c02
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NAPROXEN
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Virtus Pharmaceuticals, LLC
Application: ANDA091432
Marketing category: ANDA
Marketing start: 2019-11-15
Marketing end: 0000-00-00
Substance: NAPROXEN
Active strength: 375 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69543-425		D	Discontinued by firm		2026-08-07
excluded package	package	69543-425	69543-425-10	D	Discontinued by firm		2026-08-07

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69543-425-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69543-425-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69543-425-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69543-425-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69543-425-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69543-425-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69543-425-10	`302b2466d912…`	`e7b80fea0513…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091432-001	NAPROXEN	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB		2011-09-19
A091432-002	NAPROXEN	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB		2011-09-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091432-001	AB
A091432-002	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 3 · 82 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	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A091432-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091432-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091432-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091432-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091432-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091432-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091432-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091432-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091432-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091432-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091432-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091432-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091432-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091432-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091432-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091432-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091432-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091432-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091432-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091432-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091432-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091432-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091432-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091432-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091432-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091432-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091432-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091432-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091432-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091432-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091432-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091432-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091432-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091432-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091432-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091432-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091432-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091432-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091432-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091432-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69543-425-10	EA - Each	69543-425	ce480872-2256-40bb-ba46-cfc55af49c79	1	2019-11-12

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	Cameron Pharmaceuticals	2ae474dd-eaae-4401-8d42-613d672daea0	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091432 application number: ANDA091432
Naproxen	NAPROXEN	Sunrise Pharmaceutical, Inc.	f2fb222a-b854-4e6f-9027-2e08aed24185	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091432 application number: ANDA091432
Naproxen	NAPROXEN	PD-Rx Pharmaceuticals, Inc.	2d01e583-670a-46f4-b5f2-3fad46d0376f	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091432 application number: ANDA091432
Naproxen	NAPROXEN	Bryant Ranch Prepack	124af155-0661-4054-9800-de547d8212d7	2025-09-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091432 application number: ANDA091432
Naproxen	NAPROXEN	NuCare Pharmaceuticals,Inc.	5e873524-f9fb-fe2d-e053-2991aa0aa0a5	2024-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091432 application number: ANDA091432
Naproxen	NAPROXEN	Bryant Ranch Prepack	74134b90-d4c7-41bd-a1bd-2ac168db596f	2024-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091432 application number: ANDA091432
Naproxen	NAPROXEN	Proficient Rx LP	69a3afd6-d64b-4f07-b848-b0d3fc19f2a2	2019-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091432 application number: ANDA091432
Naproxen	NAPROXEN	Cipla USA Inc.	e06c2b43-9882-442e-8413-10d9a33aecb9	2019-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091432 application number: ANDA091432

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69543-425-10	69543042510	100 TABLET, DELAYED RELEASE in 1 BOTTLE (69543-425-10)	2019-11-15	0000-00-00	No	No	Current