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 43.

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 · 48 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
2026-09-14 22:38:34	2026-08	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216908-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216908-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2023-05-31	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A216908-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A216908-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A216908-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A216908-002	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

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

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	Historical