Naproxen

Product NDC: 0093-1005
11-digit product format: 000931005
Labeler code: 0093
Product ID: 0093-1005_7adf6304-d32e-4642-94dc-5f2d906b9a27
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA075227
Marketing category: ANDA
Marketing start: 1998-07-31
Marketing end: 0000-00-00
Substance: NAPROXEN
Active strength: 375 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: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0093-1005		D	Discontinued by firm	2026-08-17
excluded package	package	0093-1005	0093-1005-01	D	Discontinued by firm	2026-08-17
excluded package	package	0093-1005	0093-1005-05	D	Discontinued by firm	2026-08-17

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 · 6 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	0093-1005-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0093-1005-01	`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	0093-1005-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0093-1005-01	`f5e01cc5f278…`	`a2eaf40c39c3…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075227-001	NAPROXEN	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB		1998-06-30
A075227-002	NAPROXEN	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB		1998-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075227-001	AB
A075227-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075227-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075227-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	1998-06-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A075227-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075227-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075227-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075227-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075227-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075227-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075227-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075227-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075227-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075227-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075227-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075227-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075227-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075227-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075227-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075227-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075227-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075227-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075227-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075227-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075227-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075227-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075227-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075227-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075227-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075227-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075227-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075227-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075227-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A075227-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075227-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075227-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075227-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A075227-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075227-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A075227-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075227-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075227-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075227-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A075227-002	AB	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fef6ad89-235f-4274-ba49-a8e53642473e	Product name	2	20250225
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
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
0093-1005-01	EA - Each	0093-1005	68c0cc8d-747a-412c-b895-74fd0849d5d8	1	2012-07-24
0093-1005-05	EA - Each	0093-1005	dd8fe5de-07d1-4605-82e1-a16457998117	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	6
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	6
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	NAPROXEN TABLET, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	6
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN TABLET, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	6
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	NAPROXEN TABLET, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	6
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	NAPROXEN TABLET, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NAPROXEN TABLET, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	6
SHELLAC	INACTIVE INGREDIENT	46N107B71O	NAPROXEN TABLET, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	6
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NAPROXEN TABLET, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN TABLET, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN TABLET, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	6
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	NAPROXEN TABLET, DELAYED RELEASE [TEVA PHARMACEUTICALS USA INC]	6
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
NAPROXEN	ACTIVE INGREDIENT	57Y76R9ATQ	NAPROXEN TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
NAPROXEN	ACTIVE MOIETY	57Y76R9ATQ	NAPROXEN TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	NAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	NAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	NAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	NAPROXEN TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	NAPROXEN TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	NAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	NAPROXEN TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	NAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	NAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	NAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NAPROXEN TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	NAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	NAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	NAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS LLC]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	NAPROXEN TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	NAPROXEN TABLET, DELAYED RELEASE [AIDAREX PHARMACEUTICALS 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
603103	naproxen 375 MG Delayed Release Oral Tablet	PSN	7df1152f-50c0-0571-e053-2991aa0a4437	2
603103	naproxen 375 MG Delayed Release Oral Tablet	SCD	7df1152f-50c0-0571-e053-2991aa0a4437	2
603103	naproxen 375 MG (as naproxen sodium 413 MG) Delayed Release Oral Tablet	SY	7df1152f-50c0-0571-e053-2991aa0a4437	2
603103	naproxen 375 MG Delayed Release Oral Tablet	PSN	14e4b008-ae31-4b40-a227-1445367e09ed	1
311915	naproxen 500 MG Delayed Release Oral Tablet	PSN	14e4b008-ae31-4b40-a227-1445367e09ed	1
311915	naproxen 500 MG Delayed Release Oral Tablet	PSN	afebcc90-e2b5-416d-a041-db2dd593a648	1
603103	naproxen 375 MG Delayed Release Oral Tablet	SCD	14e4b008-ae31-4b40-a227-1445367e09ed	1
311915	naproxen 500 MG Delayed Release Oral Tablet	SCD	14e4b008-ae31-4b40-a227-1445367e09ed	1
311915	naproxen 500 MG Delayed Release Oral Tablet	SCD	afebcc90-e2b5-416d-a041-db2dd593a648	1
311915	naproxen (as naproxen sodium) 500 MG Delayed Release Oral Tablet	SY	14e4b008-ae31-4b40-a227-1445367e09ed	1
311915	naproxen (as naproxen sodium) 500 MG Delayed Release Oral Tablet	SY	afebcc90-e2b5-416d-a041-db2dd593a648	1
603103	naproxen 375 MG (as naproxen sodium 413 MG) Delayed Release Oral Tablet	SY	14e4b008-ae31-4b40-a227-1445367e09ed	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0093-1005-01	00093100501	100 TABLET, DELAYED RELEASE in 1 BOTTLE (0093-1005-01)	1998-07-31	0000-00-00	No	No	Current
0093-1005-05	00093100505	500 TABLET, DELAYED RELEASE in 1 BOTTLE (0093-1005-05)	1998-07-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naproxen	Teva Pharmaceuticals USA, Inc.	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	17
Naproxen	Proficient Rx LP	2024-10-01	HUMAN PRESCRIPTION DRUG LABEL	4
Naproxen	Preferred Pharmaceuticals Inc.	2020-07-28	HUMAN PRESCRIPTION DRUG LABEL	3
Naproxen	medsource pharmaceuticals	2019-12-27	HUMAN PRESCRIPTION DRUG LABEL	2
Naproxen	REMEDYREPACK INC.	2019-08-14	HUMAN PRESCRIPTION DRUG LABEL	3
NAPROXEN DELAYED-RELEASE TABLETS USP 1005 1006 Rx only	Aidarex Pharmaceuticals LLC	2014-01-16	HUMAN PRESCRIPTION DRUG LABEL	1
NAPROXEN DELAYED-RELEASE TABLETS Rx only	Rebel Distributors Corp	2011-01-17	HUMAN PRESCRIPTION DRUG LABEL	1