Naproxen and esomeprazole magnesium

Product NDC: 85509-1203
11-digit product format: 855091203
Labeler code: 85509
Product ID: 85509-1203_3c550f7b-3a41-f64f-e063-6394a90ab3a9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naproxen and esomeprazole magnesium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: PHOENIX RX LLC
Application: ANDA213699
Marketing category: ANDA
Marketing start: 2022-10-06
Substance: ESOMEPRAZOLE MAGNESIUM; NAPROXEN
Active strength: 20; 500 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: 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	85509-1203	85509-1203-6	D	Discontinued by firm		2026-08-03

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	85509-1203	85509-1203-6	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	85509-1203	85509-1203-6	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
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 · 52 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	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…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213699-001	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;375MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213699-002	NAPROXEN AND ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE;500MG	TABLET, DELAYED RELEASE / ORAL	AB	2022-10-06	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 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	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…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213699-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213699-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213699-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213699-002	AB	1	`a67488948f0b…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NAPROXEN	20 mg/1
ESOMEPRAZOLE MAGNESIUM	500 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
994008	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
3a652450-525b-4839-e063-6294a90ac287	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1	Product name	6	20251027
fef6ad89-235f-4274-ba49-a8e53642473e	Product name	2	20250225
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
87fed3e6-8fba-48ef-96b0-3a7fb54b96ff	Product name	3	20230306
b5fdaaec-7251-4da6-9cb2-4e9e76939ec8	Product name	1	20200623
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
e76dbbc1-775d-722c-08ff-ed45e8a80def	Product name	3	20181002
d71865e8-5c35-4d76-8ecd-a7adda982240	Product name	9	20180628
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d71865e8-5c35-4d76-8ecd-a7adda982240	Product name	8	20171212
094c6751-235c-4d12-acee-2baf94f676f4	Product name	1	20151116
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
85509-1203-1	Naproxen and esomeprazole magnesium	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60	3
85509-1203-3	Naproxen and esomeprazole magnesium	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30	3
85509-1203-6	Naproxen and esomeprazole magnesium	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
85509-1203-1	EA - Each	85509-1203	3efd9ff0-fd2f-4775-af75-5d5718d4521e	1	2025-09-12
85509-1203-3	EA - Each	85509-1203	bb77a279-b07f-4655-a292-f267723dce86	1	2025-09-12
85509-1203-6	EA - Each	85509-1203	f894c4a9-01a4-48e2-a3e3-d47e1a95e8d0	1	2025-09-12

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
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 ndc (product): 85509-1203
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
R6DXU4WAY9	ESOMEPRAZOLE MAGNESIUM	217087-09-7	ESOMEPRAZOLE MAGNESIUM
57Y76R9ATQ	NAPROXEN	22204-53-1	NAPROXEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
994008	naproxen 500 MG / esomeprazole magnesium 20 MG Delayed Release Oral Tablet	PSN	3a652450-525b-4839-e063-6294a90ac287	3
994008	esomeprazole 20 MG / naproxen 500 MG Delayed Release Oral Tablet	SCD	3a652450-525b-4839-e063-6294a90ac287	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
85509-1203-1	85509120301	60 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1203-1)	2025-08-01	No	No	Current
85509-1203-3	85509120303	30 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1203-3)	2025-07-21	No	No	Current
85509-1203-6	85509120306	30 in 1 BOTTLE				Historical