Naproxen Sodium

Product NDC: 68788-7800
Requested package NDC: 68788-7800-2
11-digit product format: 687887800
Labeler code: 68788
Product ID: 68788-7800_e522f024-b4ac-4ff4-8368-e9e6da9eb37e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen Sodium
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA212199
Marketing category: ANDA
Marketing start: 2020-10-13
Substance: NAPROXEN SODIUM
Active strength: 550 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
A212199-001	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB		2019-10-30
A212199-002	NAPROXEN SODIUM	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB		2019-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212199-001	AB
A212199-002	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 · 78 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	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212199-001	NAPROXEN SODIUM	EQ 250MG BASE	TABLET / ORAL	AB	2019-10-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212199-002	NAPROXEN SODIUM	EQ 500MG BASE	TABLET / ORAL	AB	2019-10-30	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	A212199-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212199-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212199-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212199-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212199-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212199-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212199-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212199-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212199-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212199-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212199-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212199-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212199-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212199-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212199-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212199-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212199-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212199-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212199-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212199-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212199-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212199-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212199-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212199-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212199-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212199-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212199-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212199-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212199-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212199-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212199-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212199-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212199-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212199-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212199-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A212199-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212199-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212199-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212199-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212199-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPROXEN SODIUM	550 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9TN87S3A3C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
849431	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
6ae413ba-5a48-423f-8b8d-7a42661cf836	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
68788-7800-1	Naproxen Sodium	100 in 1 BOTTLE	TABLET	100	5
68788-7800-2	Naproxen Sodium	20 in 1 BOTTLE	TABLET	20	5
68788-7800-3	Naproxen Sodium	30 in 1 BOTTLE	TABLET	30	5
68788-7800-4	Naproxen Sodium	14 in 1 BOTTLE	TABLET	14	5
68788-7800-6	Naproxen Sodium	60 in 1 BOTTLE	TABLET	60	5
68788-7800-8	Naproxen Sodium	120 in 1 BOTTLE	TABLET	120	5
68788-7800-9	Naproxen Sodium	90 in 1 BOTTLE	TABLET	90	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7800	NAPROXEN SODIUM TABLET [PREFERRED PHARMACEUTICALS, INC.]	4	Current NDC, Legacy NDC, 7 package rows	20240724_6ae413ba-5a48-423f-8b8d-7a42661cf836.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen Sodium	NAPROXEN SODIUM	ScieGen Pharmaceuticals, Inc.	79f48c92-783d-40f2-9865-89958a9f9de6	2026-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199
Naproxen Sodium	NAPROXEN SODIUM	ST. MARY'S MEDICAL PARK PHARMACY	181c2d5b-2c61-bf20-e063-6294a90a3f7f	2026-05-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	2794b60d-d09b-4115-9ff2-07ff15524e78	2026-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	bee7b482-8ba5-411d-90ee-de00df50d2b7	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	e9eb8c40-85d9-4c8e-9523-a21d3591260f	2026-04-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199
Naproxen Sodium	NAPROXEN SODIUM	Bryant Ranch Prepack	f6f4a670-235e-4235-84a8-a74dc8ca5586	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199
Naproxen Sodium	NAPROXEN SODIUM	Advanced Rx of Tennessee, LLC	369911ea-9069-9c45-e063-6394a90a5ce6	2026-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199
Naproxen Sodium	NAPROXEN SODIUM	Advanced Rx of Tennessee, LLC	4a05ca8c-1b03-fa86-e063-6394a90a4119	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199
Naproxen Sodium	NAPROXEN SODIUM	PD-Rx Pharmaceuticals, Inc.	145cdcc0-9bd5-4a0e-81fc-11a24d181980	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199
Naproxen Sodium	NAPROXEN SODIUM	Preferred Pharmaceuticals, Inc.	6ae413ba-5a48-423f-8b8d-7a42661cf836	2025-08-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199 ndc (package): 68788-7800-2 ndc (product): 68788-7800 ndc11 (package): 68788780002
Naproxen Sodium	NAPROXEN SODIUM	Direct Rx	d95279d9-6e2a-0bd6-e053-2a95a90a447d	2025-01-21		Exact identifier application applno (ANDA): 212199 application number: ANDA212199
Naproxen Sodium	NAPROXEN SODIUM	NuCare Pharmaceuticals,Inc.	b8e417d2-3fc8-9a5e-e053-2a95a90a4155	2025-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199
Naproxen Sodium	NAPROXEN SODIUM	Asclemed USA, Inc.	b0571e62-9330-438d-a2ba-873477f52dc4	2023-10-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199
Naproxen Sodium	NAPROXEN SODIUM	Proficient Rx LP	a90bfc07-d01e-427c-b2df-41bff7612d2f	2022-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212199 application number: ANDA212199

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9TN87S3A3C	NAPROXEN SODIUM	26159-34-2	NAPROXEN SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
849431	naproxen sodium 550 MG Oral Tablet	PSN	6ae413ba-5a48-423f-8b8d-7a42661cf836	5
849431	naproxen sodium 550 MG Oral Tablet	SCD	6ae413ba-5a48-423f-8b8d-7a42661cf836	5
849431	naproxen sodium 550 MG (as naproxen 500 MG) Oral Tablet	SY	6ae413ba-5a48-423f-8b8d-7a42661cf836	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7800-2	68788780002	20 TABLET in 1 BOTTLE (68788-7800-2)	20 tablet	2020-10-13	0000-00-00	No	No	Current