Naproxen

Product NDC: 71205-060
11-digit product format: 712050060
Labeler code: 71205
Product ID: 71205-060_6b4c9ec2-308f-4b60-941c-34a2c7a7882c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA091432
Marketing category: ANDA
Marketing start: 2016-07-05
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: 2026-12-31
Current FDA listing: Yes

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Naproxen
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPROXEN	375 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
57Y76R9ATQ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
603103	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
69a3afd6-d64b-4f07-b848-b0d3fc19f2a2	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71205-060-14	Naproxen	14 in 1 BOTTLE	TABLET, DELAYED RELEASE	14	3
71205-060-15	Naproxen	15 in 1 BOTTLE	TABLET, DELAYED RELEASE	15	3
71205-060-20	Naproxen	20 in 1 BOTTLE	TABLET, DELAYED RELEASE	20	3
71205-060-30	Naproxen	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30	3
71205-060-40	Naproxen	40 in 1 BOTTLE	TABLET, DELAYED RELEASE	40	3
71205-060-45	Naproxen	45 in 1 BOTTLE	TABLET, DELAYED RELEASE	45	3
71205-060-60	Naproxen	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60	3
71205-060-90	Naproxen	90 in 1 BOTTLE	TABLET, DELAYED RELEASE	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71205-060-60	EA - Each	71205-060	bf31b714-79a7-4758-af9a-34b7eed4e278	1	2018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71205-060	NAPROXEN TABLET, DELAYED RELEASE [PROFICIENT RX LP]	3	Current NDC, Legacy NDC, 8 package rows	20191030_69a3afd6-d64b-4f07-b848-b0d3fc19f2a2.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 · 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 ndc (product): 71205-060
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
603103	naproxen 375 MG Delayed Release Oral Tablet	PSN	69a3afd6-d64b-4f07-b848-b0d3fc19f2a2	3
603103	naproxen 375 MG Delayed Release Oral Tablet	SCD	69a3afd6-d64b-4f07-b848-b0d3fc19f2a2	3
603103	naproxen 375 MG (as naproxen sodium 413 MG) Delayed Release Oral Tablet	SY	69a3afd6-d64b-4f07-b848-b0d3fc19f2a2	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71205-060-14	71205006014	14 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-14)	2018-06-01	0000-00-00	No	No	Current
71205-060-15	71205006015	15 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-15)	2018-06-01	0000-00-00	No	No	Current
71205-060-20	71205006020	20 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-20)	2018-06-01	0000-00-00	No	No	Current
71205-060-30	71205006030	30 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-30)	2018-06-01	0000-00-00	No	No	Current
71205-060-40	71205006040	40 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-40)	2018-06-01	0000-00-00	No	No	Current
71205-060-45	71205006045	45 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-45)	2018-06-01	0000-00-00	No	No	Current
71205-060-60	71205006060	60 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-60)	2018-06-01	0000-00-00	No	No	Current
71205-060-90	71205006090	90 TABLET, DELAYED RELEASE in 1 BOTTLE (71205-060-90)	2018-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naproxen Delayed-release Tablets USP, 375 mg and 500 mg Rx only	Proficient Rx LP	2019-10-01	HUMAN PRESCRIPTION DRUG LABEL	3