Naproxen

Product NDC: 70518-3822
11-digit product format: 705183822
Labeler code: 70518
Product ID: 70518-3822_3f665aca-7ee1-dce4-e063-6394a90a3075
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA212517
Marketing category: ANDA
Marketing start: 2023-08-06
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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-3822	70518-3822-6	D	Discontinued by firm		2026-08-11

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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A212517-001	NAPROXEN	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21
A212517-002	NAPROXEN	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21
A212517-003	NAPROXEN	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A212517-001	AB
A212517-002	AB
A212517-003	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 · 111 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	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212517-002	NAPROXEN	375MG	TABLET / ORAL	AB	2020-02-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212517-003	NAPROXEN	500MG	TABLET / ORAL	AB	2020-02-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212517-001	NAPROXEN	250MG	TABLET / ORAL	AB	2020-02-21	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 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	A212517-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212517-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212517-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212517-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212517-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212517-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212517-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212517-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212517-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212517-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212517-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212517-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212517-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212517-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212517-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212517-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212517-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212517-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212517-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212517-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212517-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212517-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212517-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212517-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Naproxen
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198014	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
ccd95dfc-9236-4707-a715-6a12c91519ff	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
70518-3822-0	Naproxen	30 in 1 BLISTER PACK	TABLET	30	8
70518-3822-1	Naproxen	60 in 1 BOTTLE, PLASTIC	TABLET	60	8
70518-3822-2	Naproxen	20 in 1 BOTTLE, PLASTIC	TABLET	20	8
70518-3822-3	Naproxen	30 in 1 BOTTLE, PLASTIC	TABLET	30	8
70518-3822-4	Naproxen	14 in 1 BOTTLE, PLASTIC	TABLET	14	8
70518-3822-5	Naproxen	6 in 1 BLISTER PACK	TABLET	6	8
70518-3822-6	Naproxen	28 in 1 BOTTLE, PLASTIC	TABLET	28	8
70518-3822-7	Naproxen	12 in 1 BOTTLE, PLASTIC	TABLET	12	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70518-3822-1	EA - Each	70518-3822	0b97331a-046f-43a9-bf82-107d3c25e09c	1	2026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3822	NAPROXEN TABLET [REMEDYREPACK INC.]	7	Current NDC, 8 package rows	20241204_ccd95dfc-9236-4707-a715-6a12c91519ff.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 2 · 39 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen	NAPROXEN	PD-Rx Pharmaceuticals, Inc.	24d44eb6-921e-4150-a6b2-81f42ced32ab	2026-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Preferred Pharmaceuticals Inc.	49a00870-f580-4eb9-a95d-48fa956f147f	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Preferred Pharmaceuticals, Inc.	9f026fd5-f996-4383-b528-841d38d3dab5	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	HAWAII REPACK, INC.	888efc91-b4de-4691-b84c-fb871e7a6dfe	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	St. Mary's Medical Park Pharmacy	e3a3e5d2-2d1e-74d3-e053-2995a90a82bf	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	REMEDYREPACK INC.	ccd95dfc-9236-4707-a715-6a12c91519ff	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517 ndc (product): 70518-3822
Naproxen	NAPROXEN	ST. MARY'S MEDICAL PARK PHARMACY	e3a4ab4a-b109-eb5e-e053-2a95a90afddd	2026-06-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Bryant Ranch Prepack	2e72de28-e62b-44e0-b17d-500d13e0bcc6	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Bryant Ranch Prepack	bbc61c0a-491a-4f50-a7bf-2ca94c771568	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Sportpharm LLC	1c5b2bc1-26bb-4f88-bded-399263c82331	2026-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Bryant Ranch Prepack	f18181f4-6b14-48a8-a149-e45b3360a250	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Bryant Ranch Prepack	97d6c4ef-13b1-4b0b-a15a-f0590019940d	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Bryant Ranch Prepack	852fed15-e78b-47a8-aeb4-623dfe1edad9	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	REMEDYREPACK INC.	6bb65680-76ea-46e5-ae70-f3091e360368	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Radha Pharmaceuticals, Inc.	1a2b9a82-5b79-45ee-94ed-7a6f8c8b5170	2026-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	ScieGen Pharmaceuticals, Inc.	81e22c1f-f94d-46e9-8b7d-72dc2518319e	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	NuCare Pharmaceuticals,Inc.	c136cf75-4ad4-8634-e053-2a95a90a53a4	2026-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	PD-Rx Pharmaceuticals, Inc.	fa2fe6fd-c476-dd29-e053-6294a90a9e9e	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Northwind Health Company, LLC	db478961-d984-7c8e-e053-2995a90a8a12	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517
Naproxen	NAPROXEN	Northwind Health Company, LLC	c986ba9a-6f48-8347-e053-2a95a90aa1c1	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212517 application number: ANDA212517

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
198014	naproxen 500 MG Oral Tablet	PSN	ccd95dfc-9236-4707-a715-6a12c91519ff	8
198014	naproxen 500 MG Oral Tablet	SCD	ccd95dfc-9236-4707-a715-6a12c91519ff	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-3822-0	70518382200	30 TABLET in 1 BLISTER PACK (70518-3822-0)	30 tablet	2023-08-06	No	No	Current
70518-3822-1	70518382201	60 TABLET in 1 BOTTLE, PLASTIC (70518-3822-1)	60 tablet	2023-08-23	No	No	Current
70518-3822-2	70518382202	20 TABLET in 1 BOTTLE, PLASTIC (70518-3822-2)	20 tablet	2023-08-23	No	No	Current
70518-3822-3	70518382203	30 TABLET in 1 BOTTLE, PLASTIC (70518-3822-3)	30 tablet	2023-08-24	No	No	Current
70518-3822-4	70518382204	14 TABLET in 1 BOTTLE, PLASTIC (70518-3822-4)	14 tablet	2023-08-24	No	No	Current
70518-3822-5	70518382205	6 TABLET in 1 BLISTER PACK (70518-3822-5)	6 tablet	2023-09-09	No	No	Current
70518-3822-6	70518382206	28 in 1 BOTTLE, PLASTIC					Historical
70518-3822-7	70518382207	12 TABLET in 1 BOTTLE, PLASTIC (70518-3822-7)	12 tablet	2024-02-23	No	No	Current