Naproxen

Product NDC: 70954-928
11-digit product format: 709540928
Labeler code: 70954
Product ID: 70954-928_5c522cd1-1631-4254-ae44-cef65573b29f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: ANI Pharmaceuticals, Inc.
Application: ANDA218497
Marketing category: ANDA
Marketing start: 2024-06-13
Substance: NAPROXEN
Active strength: 500 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
A218497-001	NAPROXEN	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB		2024-06-12
A218497-002	NAPROXEN	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB		2024-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A218497-001	AB
A218497-002	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.

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	A218497-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218497-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218497-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218497-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218497-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218497-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218497-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218497-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218497-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218497-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218497-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218497-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218497-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218497-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218497-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218497-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218497-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218497-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218497-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218497-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218497-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218497-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218497-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218497-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218497-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218497-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218497-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218497-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218497-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218497-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218497-001	NAPROXEN	375MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218497-002	NAPROXEN	500MG	TABLET, DELAYED RELEASE / ORAL	AB	2024-06-12	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218497-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218497-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218497-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218497-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218497-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218497-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218497-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218497-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218497-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218497-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218497-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A218497-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218497-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A218497-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218497-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A218497-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218497-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A218497-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218497-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A218497-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218497-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A218497-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A218497-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A218497-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218497-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A218497-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218497-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A218497-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218497-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A218497-002	AB	1	`1e350fbaab3a…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218497-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218497-002	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPROXEN	500 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
052e6fe3-d619-42c3-b64e-67c7aaf7271c	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
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
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
70954-928-10	Naproxen	100 in 1 BOTTLE	TABLET, DELAYED RELEASE	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70954-928-10	EA - Each	70954-928	71c99840-de4b-41a8-b1d7-6e2aaff9002c	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70954-928	NAPROXEN TABLET, DELAYED RELEASE [ANI PHARMACEUTICALS, INC.]	2	Current NDC, 1 package rows	20250410_052e6fe3-d619-42c3-b64e-67c7aaf7271c.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	ANI Pharmaceuticals, Inc.	052e6fe3-d619-42c3-b64e-67c7aaf7271c	2025-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218497 application number: ANDA218497 ndc (product): 70954-928

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	052e6fe3-d619-42c3-b64e-67c7aaf7271c	2
311915	naproxen 500 MG Delayed Release Oral Tablet	PSN	052e6fe3-d619-42c3-b64e-67c7aaf7271c	2
603103	naproxen 375 MG Delayed Release Oral Tablet	SCD	052e6fe3-d619-42c3-b64e-67c7aaf7271c	2
311915	naproxen 500 MG Delayed Release Oral Tablet	SCD	052e6fe3-d619-42c3-b64e-67c7aaf7271c	2
311915	naproxen (as naproxen sodium) 500 MG Delayed Release Oral Tablet	SY	052e6fe3-d619-42c3-b64e-67c7aaf7271c	2
603103	naproxen 375 MG (as naproxen sodium 413 MG) Delayed Release Oral Tablet	SY	052e6fe3-d619-42c3-b64e-67c7aaf7271c	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70954-928-10	70954092810	100 TABLET, DELAYED RELEASE in 1 BOTTLE (70954-928-10)	2024-06-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naproxen	ANI Pharmaceuticals, Inc. \| Novitium Pharma LLC	2025-03-12	Human Prescription Drug Label	2