Naproxen

Product NDC: 52817-380
11-digit product format: 528170380
Labeler code: 52817
Product ID: 52817-380_28a0f21b-859f-0459-e063-6394a90a08e0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: TruPharma LLC
Application: ANDA216908
Marketing category: ANDA
Marketing start: 2023-07-27
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
A216908-001	NAPROXEN	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB		2023-05-31
A216908-002	NAPROXEN	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB		2023-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A216908-001	AB
A216908-002	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 2 · 44 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	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 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	A216908-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216908-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216908-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216908-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216908-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216908-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216908-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216908-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216908-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216908-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216908-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216908-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216908-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216908-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216908-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216908-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216908-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216908-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216908-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216908-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216908-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216908-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216908-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216908-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216908-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216908-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216908-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A216908-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216908-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A216908-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A216908-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A216908-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A216908-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A216908-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216908-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A216908-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216908-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A216908-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216908-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A216908-002	AB	1	`a67488948f0b…`

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
311915	Internal RxNorm lookup
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
004bb832-29d5-add0-e063-6394a90a90f4	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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	Strength	SPL version
52817-380-10	Naproxen	100 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	100		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52817-380	NAPROXEN TABLET, DELAYED RELEASE [TRUPHARMA LLC]	3	Current NDC, 1 package rows	20241218_004bb832-29d5-add0-e063-6394a90a90f4.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	TruPharma LLC	004bb832-29d5-add0-e063-6394a90a90f4	2024-12-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216908 application number: ANDA216908 ndc (product): 52817-380

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	004bb832-29d5-add0-e063-6394a90a90f4	3
311915	naproxen 500 MG Delayed Release Oral Tablet	PSN	004bb832-29d5-add0-e063-6394a90a90f4	3
603103	naproxen 375 MG Delayed Release Oral Tablet	SCD	004bb832-29d5-add0-e063-6394a90a90f4	3
311915	naproxen 500 MG Delayed Release Oral Tablet	SCD	004bb832-29d5-add0-e063-6394a90a90f4	3
311915	naproxen (as naproxen sodium) 500 MG Delayed Release Oral Tablet	SY	004bb832-29d5-add0-e063-6394a90a90f4	3
603103	naproxen 375 MG (as naproxen sodium 413 MG) Delayed Release Oral Tablet	SY	004bb832-29d5-add0-e063-6394a90a90f4	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
52817-380-10	52817038010	100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (52817-380-10)	2023-08-01	No	No	Current