Esomeprazole Magnesium

Product NDC: 71335-3149
11-digit product format: 713353149
Labeler code: 71335
Product ID: 71335-3149_c60205a1-bb99-4068-bc4e-ce4f1c36844e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Esomeprazole magnesium
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA213859
Marketing category: ANDA
Marketing start: 2023-08-15
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
A213859-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2020-11-18
A213859-002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2020-11-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213859-001	AB
A213859-002	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 · 76 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	A213859-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213859-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213859-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213859-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213859-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213859-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213859-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213859-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213859-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213859-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213859-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213859-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213859-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213859-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213859-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213859-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213859-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213859-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213859-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213859-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213859-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213859-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213859-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213859-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213859-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213859-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213859-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213859-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213859-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213859-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213859-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213859-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213859-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2020-11-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213859-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2020-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213859-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2020-11-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213859-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2020-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213859-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2020-11-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213859-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2020-11-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213859-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2020-11-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213859-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL		2020-11-18	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 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	A213859-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213859-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213859-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213859-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213859-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213859-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213859-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213859-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213859-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213859-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213859-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213859-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213859-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213859-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213859-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213859-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213859-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213859-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213859-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213859-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213859-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213859-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213859-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213859-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213859-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213859-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213859-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213859-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213859-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213859-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213859-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213859-002	AB	1	`8072bd15b7f6…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213859-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213859-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213859-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A213859-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213859-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A213859-002	AB	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213859-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213859-002	AB	1	`6a51e52b5d6a…`

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
81f5f7d9-14bb-4804-975e-65d96f91785f	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	81f5f7d9-14bb-4804-975e-65d96f91785f	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213859 application number: ANDA213859 ndc (product): 71335-3149
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	b58bfbdb-939e-456e-827d-068e9d808840	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213859 application number: ANDA213859
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	8a8ca4cf-076c-48c9-8613-f5a1bae87a49	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213859 application number: ANDA213859
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Preferred Pharmaceuticals Inc.	e264d9c8-5ba9-49c1-9b27-d6ff9a6a45ba	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213859 application number: ANDA213859
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	3a879cfc-b0a4-48ca-aa6a-b5e9051601aa	2024-12-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213859 application number: ANDA213859
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Somerset Therapeutics, LLC	02893318-e394-5a8e-e063-6394a90a885a	2024-11-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213859 application number: ANDA213859

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-3149-1	71335314901	90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-3149-1)	2026-06-18	No	No	Current
71335-3149-2	71335314902	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-3149-2)	2026-06-18	No	No	Current
71335-3149-3	71335314903	60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-3149-3)	2026-06-18	No	No	Current
71335-3149-4	71335314904	10 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-3149-4)	2026-06-18	No	No	Current
71335-3149-5	71335314905	20 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-3149-5)	2026-06-18	No	No	Current
71335-3149-6	71335314906	120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-3149-6)	2026-06-18	No	No	Current
71335-3149-7	71335314907	180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-3149-7)	2026-06-18	No	No	Current