esomeprazole magnesium

Product NDC: 70518-3850
11-digit product format: 705183850
Labeler code: 70518
Product ID: 70518-3850_53d62c6b-a17e-5bd5-e063-6394a90a2a50
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: esomeprazole magnesium
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA213486
Marketing category: ANDA
Marketing start: 2023-09-02
Substance: ESOMEPRAZOLE MAGNESIUM
Active strength: 40 mg/1
Pharmacologic classes: Cytochrome P450 2C19 Inhibitors [MoA], 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
A213486-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2021-03-19
A213486-002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2021-03-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213486-001	AB
A213486-002	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 · 72 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	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213486-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213486-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2021-03-19	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 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	A213486-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213486-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213486-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213486-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213486-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213486-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213486-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213486-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213486-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213486-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213486-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213486-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213486-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213486-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213486-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213486-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213486-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213486-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213486-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213486-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213486-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213486-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213486-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213486-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213486-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213486-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213486-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213486-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213486-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213486-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213486-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213486-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213486-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213486-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213486-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213486-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213486-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213486-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213486-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213486-002	AB	1	`bb7c543d1eb4…`

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: esomeprazole magnesium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESOMEPRAZOLE MAGNESIUM	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
606730	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
e6e1906f-60be-402f-97f4-6d7bea1a6c08	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
d71865e8-5c35-4d76-8ecd-a7adda982240	Product name	9	20180628
d71865e8-5c35-4d76-8ecd-a7adda982240	Product name	8	20171212
094c6751-235c-4d12-acee-2baf94f676f4	Product name	1	20151116
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
70518-3850-0	esomeprazole magnesium	30 in 1 BOTTLE, PLASTIC	CAPSULE, DELAYED RELEASE	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3850	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [REMEDYREPACK INC.]	2	Current NDC, 1 package rows	20240403_e6e1906f-60be-402f-97f4-6d7bea1a6c08.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	REMEDYREPACK INC.	e6e1906f-60be-402f-97f4-6d7bea1a6c08	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213486 application number: ANDA213486 ndc (product): 70518-3850
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Preferred Pharmaceuticals Inc.	2d21ed0b-a089-46f4-9ebb-f24f9f3af61d	2025-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213486 application number: ANDA213486
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	Quallent Pharmaceuticals Health LLC	7362f930-0879-451e-8de9-8bb8565bfb7e	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213486 application number: ANDA213486
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Biocon Pharma Inc.,	66c9e2bf-2dc4-4683-89fd-6dadf1b01ee9	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213486 application number: ANDA213486
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	NuCare Pharmaceuticals,Inc.	fe7d7aa8-4f46-83ae-e053-6394a90a01d6	2025-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213486 application number: ANDA213486
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	f99f95a2-60e4-4781-80a9-e5b12897dff1	2024-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213486 application number: ANDA213486
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	2f1b1a56-b6c4-4e30-a1f7-12701aa5a535	2024-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213486 application number: ANDA213486
esomeprazole magnesium	ESOMEPRAZOLE MAGNESIUM	Proficient Rx LP	7b92ac4f-50c9-4061-b4a7-535a58cea8f6	2024-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213486 application number: ANDA213486

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R6DXU4WAY9	ESOMEPRAZOLE MAGNESIUM	217087-09-7	ESOMEPRAZOLE MAGNESIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
606730	esomeprazole magnesium 40 MG Delayed Release Oral Capsule	PSN	e6e1906f-60be-402f-97f4-6d7bea1a6c08	3
606730	esomeprazole 40 MG Delayed Release Oral Capsule	SCD	e6e1906f-60be-402f-97f4-6d7bea1a6c08	3
606730	esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral Capsule	SY	e6e1906f-60be-402f-97f4-6d7bea1a6c08	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70518-3850-0	70518385000	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-3850-0)	2023-09-02	No	No	Current