Naproxen

Product NDC: 0143-1347
11-digit product format: 001431347
Labeler code: 0143
Product ID: 0143-1347_d3608c5b-5040-4857-aa95-f1875166a035
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET
Route: ORAL
Labeler: West-Ward Pharmaceuticals Corp
Application: ANDA076494
Marketing category: ANDA
Marketing start: 2004-01-14
Marketing end: 0000-00-00
Substance: NAPROXEN
Active strength: 375 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0143-1347		D	Discontinued by firm	2026-08-11
excluded package	package	0143-1347	0143-1347-01	D	Discontinued by firm	2026-08-11
excluded package	package	0143-1347	0143-1347-05	D	Discontinued by firm	2026-08-11
excluded package	package	0143-1347	0143-1347-30	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 · 48 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	0143-1347-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0143-1347-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0143-1347-01	`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	0143-1347-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0143-1347-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0143-1347-01	`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	0143-1347-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0143-1347-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0143-1347-01	`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	0143-1347-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0143-1347-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0143-1347-01	`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	0143-1347-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0143-1347-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0143-1347-01	`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	0143-1347-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0143-1347-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0143-1347-01	`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	0143-1347-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0143-1347-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0143-1347-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0143-1347-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0143-1347-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0143-1347-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0143-1347-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0143-1347-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0143-1347-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0143-1347-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0143-1347-05	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0143-1347-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0143-1347-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0143-1347-05	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0143-1347-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0143-1347-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0143-1347-05	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0143-1347-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	Approval date
A076494-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	2004-01-14
A076494-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	2004-01-14
A076494-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	2004-01-14

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076494-002	NAPROXEN	375MG	TABLET / ORAL	2004-01-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076494-003	NAPROXEN	500MG	TABLET / ORAL	2004-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076494-001	NAPROXEN	250MG	TABLET / ORAL	2004-01-14	`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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0143-1347-01	EA - Each	0143-1347	4839cffd-bdd9-46ac-b860-d7dc1e533055	1	2012-07-24
0143-1347-05	EA - Each	0143-1347	90cc6c93-f18f-415a-90c2-819bf51bb828	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET [STAT RX USA LLC]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET [STAT RX USA LLC]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	NAPROXEN TABLET [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET [STAT RX USA LLC]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN TABLET [STAT RX USA LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	NAPROXEN TABLET [STAT RX USA LLC]	1

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
198012	naproxen 375 MG Oral Tablet	PSN	0a27f628-8089-41ba-b45e-4f03551aeafd	1
198012	naproxen 375 MG Oral Tablet	SCD	0a27f628-8089-41ba-b45e-4f03551aeafd	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NAPROXEN TABLETS, USP - 375 MG	STAT Rx USA LLC \| PSS World Medical Inc.	2012-04-25	HUMAN PRESCRIPTION DRUG LABEL	1