Naproxen and esomeprazole magnesium

Product NDC: 68788-4166
Requested package NDC: 68788-4166-6
11-digit product format: 687884166
Labeler code: 68788
Product ID: 68788-4166_65b892f2-8385-4bb0-8121-a58b01e8d13d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen and esomeprazole magnesium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA213699
Marketing category: ANDA
Marketing start: 2026-07-23
Substance: NAPROXEN; ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
Active strength: 375; 20 mg/1; mg/1
Pharmacologic classes: Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB		2022-10-06
A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM; NAPROXEN	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB		2022-10-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213699-001	AB
A213699-002	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 · 56 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	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`a72a2bbeb626…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 56 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	A213699-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213699-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213699-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213699-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213699-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213699-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213699-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213699-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213699-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213699-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213699-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213699-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213699-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213699-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213699-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213699-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213699-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213699-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213699-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213699-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213699-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213699-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213699-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213699-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213699-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213699-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213699-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213699-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213699-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213699-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213699-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213699-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213699-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213699-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213699-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213699-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213699-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213699-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213699-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213699-002	AB	1	`a72a2bbeb626…`

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 and esomeprazole magnesium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPROXEN	375 mg/1
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
57Y76R9ATQ	Internal UNII lookup
R6DXU4WAY9	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
994005	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
65b892f2-8385-4bb0-8121-a58b01e8d13d	Available on FDA.report

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naproxen and esomeprazole magnesium	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	Preferred Pharmaceuticals Inc.	65b892f2-8385-4bb0-8121-a58b01e8d13d	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213699 application number: ANDA213699 ndc (package): 68788-4166-6 ndc (product): 68788-4166 ndc11 (package): 68788416606
Naproxen and esomeprazole magnesium	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	Proficient Rx LP	5fd008ef-8388-48e9-8d38-76e0106bd5b6	2026-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213699 application number: ANDA213699
Naproxen and esomeprazole magnesium	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	Preferred Pharmaceuticals Inc.	b295a90e-320f-4414-b80a-d11f06c00c96	2026-01-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213699 application number: ANDA213699
Naproxen and esomeprazole magnesium	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	Ajanta Pharma USA Inc.	7ca657dc-4376-4693-8568-99351fac8186	2025-12-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213699 application number: ANDA213699
Naproxen and esomeprazole magnesium	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	PHOENIX RX LLC	3a652450-525b-4839-e063-6294a90ac287	2025-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213699 application number: ANDA213699
Naproxen and esomeprazole magnesium	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	PHOENIX RX LLC	3a6637ca-0c55-f648-e063-6294a90aaef7	2025-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213699 application number: ANDA213699
Naproxen and esomeprazole magnesium	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	19aadd4b-647b-4c75-9059-9a2c68a18561	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213699 application number: ANDA213699

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
57Y76R9ATQ	NAPROXEN	22204-53-1	NAPROXEN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68788-4166-6	68788416606	60 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-4166-6)	2026-07-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naproxen and esomeprazole magnesium	Preferred Pharmaceuticals Inc.	2026-07-23	HUMAN PRESCRIPTION DRUG LABEL	1