Naproxen Delayed Release

Manufacturer: Northwind Pharmaceuticals
Effective date: 2014-06-03
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:36:05

Label at a glance#

ProductNaproxen Delayed Release

Active ingredientNAPROXEN

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 51655-628-52

MFG: 31722-339-01

Naproxen Delayed Release 500mg

30 tablets

Rx only

Lot#:

Exp. Date:

Each tablet contains naproxen 500 mg

Dosage: See package insert

Store at 68 to 77 degrees F.

Store in a tight, light-resistant container (See USP). Keep out of the reach of children.

Mfg by: InvaGen Pharmaceuticals, Inc Hauppage, NY 11788 for Camber Pharmaceuticals, Piscataway, NJ 08854

Lot# Exp:

Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256

Naproxen 51655-628

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Code 39	NW50320001		Naproxen 51655-628.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-628-52	2026-01-08	C162847	48780-1	9d75b9d0-7c1b-f424-e053-dadaa90a57ce	c66b0b05-84b4-4f0c-82b2-f0c386f6f64f
51655-628-52	2020-01-31	C162847	48780-1	9d75b9d0-7c1b-f424-e053-dadaa90a57ce	c66b0b05-84b4-4f0c-82b2-f0c386f6f64f

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-628	NAPROXEN DELAYED RELEASE TABLET, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS]	1	Legacy NDC	20140603_c66b0b05-84b4-4f0c-82b2-f0c386f6f64f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-339-01	EA - Each	31722-339	32fab88b-2546-4fb0-affb-67cc227e4c50	1	2012-07-24
31722-339-05	EA - Each	31722-339	f7adaa65-e901-4a7f-8479-75366991f577	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version	Uploaded
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

Naproxen Delayed Release
NAPROXEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51655-628	51655-628-52
31722-339

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
NAPROXEN	57Y76R9ATQ	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 88 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
2026-10-15 13:18:30	2026-09	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091432-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091432-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2011-09-19	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A091432-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A091432-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A091432-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091432-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091432-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091432-002	AB	1	`caaa826d4ba7…`
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…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
47b9be84-9cfd-d5a9-e063-6394a90aa010			c66b0b05-84b4-4f0c-82b2-f0c386f6f64f	2026-01-06		Exact identifier spl set id: c66b0b05-84b4-4f0c-82b2-f0c386f6f64f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.