Esomeprazole Magnesium

Product NDC: 80425-0419
Requested package NDC: 80425-0419-1
11-digit product format: 804250419
Labeler code: 80425
Product ID: 80425-0419_1d8bcbd7-393e-9c1d-e063-6394a90a823c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Esomeprazole Magnesium
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Advanced Rx of Tennessee, LLC
Application: ANDA211977
Marketing category: ANDA
Marketing start: 2024-07-18
Substance: ESOMEPRAZOLE MAGNESIUM
Active strength: 20 mg/1
Pharmacologic classes: Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
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 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
A211977-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2020-06-02
A211977-002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB		2020-06-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211977-001	AB
A211977-002	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
2026-09-14 22:38:34	2026-08	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211977-001	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211977-002	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE	CAPSULE, DELAYED REL PELLETS / ORAL	AB	2020-06-02	`bb7c543d1eb4…`

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
2026-09-14 22:38:34	2026-08	A211977-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211977-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211977-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211977-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211977-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211977-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211977-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211977-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211977-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211977-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211977-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211977-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211977-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211977-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211977-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211977-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211977-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211977-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211977-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211977-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211977-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211977-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211977-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211977-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211977-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211977-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211977-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211977-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211977-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211977-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211977-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211977-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211977-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211977-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211977-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211977-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211977-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211977-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211977-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211977-002	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: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESOMEPRAZOLE MAGNESIUM	20 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
606726	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
1d8bd104-66d4-8c19-e063-6394a90a3cb6	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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	SPL version
80425-0419-1	Esomeprazole Magnesium	30 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	30	1
80425-0419-2	Esomeprazole Magnesium	60 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	60	1
80425-0419-3	Esomeprazole Magnesium	90 in 1 BOTTLE	CAPSULE, DELAYED RELEASE	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0419-1	EA - Each	80425-0419	9a1cab5a-53b4-4037-be97-f21e1c026757	1	2024-09-09
80425-0419-2	EA - Each	80425-0419	77768fca-52c9-4d42-b047-552fd494d39c	1	2024-09-09
80425-0419-3	EA - Each	80425-0419	25dd950e-374d-46f6-b7ba-03ec98bc3d12	1	2024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0419	ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [ADVANCED RX OF TENNESSEE, LLC]	1	Current NDC, 3 package rows	20240802_1d8bd104-66d4-8c19-e063-6394a90a3cb6.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
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	American Health Packaging	9a3df29e-dc44-4dfe-a26f-4bbbf18e31eb	2026-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	REMEDYREPACK INC.	ab3d31c8-cab1-4c44-bacd-5e5c67dd1384	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	27e7f7f0-7403-4425-8baa-d12ae9321364	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	00aa81c2-73c7-4bf8-94e9-f644381b631f	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Asclemed USA, Inc.	2690dbe7-e559-4de8-9582-79b627af1964	2025-01-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole DR	ESOMEPRAZOLE DR	Direct_Rx	e8937778-8baf-05f5-e053-2995a90a3a98	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	Direct Rx	d5f56bd4-3a59-6857-e053-2995a90a6e00	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium DR	ESOMEPRAZOLE MAGNESIUM	Advanced Rx Pharmacy of Tennessee, LLC	fab87a2d-79c8-6045-e053-6394a90a2368	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	A-S Medication Solutions	42b8d3f5-d919-48dd-92e4-ed49488dd664	2024-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	7778bf7c-52f7-44b3-ac2c-e5a25f6967b7	2024-08-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Bryant Ranch Prepack	61cc0020-aab8-42a3-b0a6-93062f382c87	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Advanced Rx of Tennessee, LLC	1e92676a-6c59-796d-e063-6294a90aaab4	2024-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Advanced Rx of Tennessee, LLC	1d8bd104-66d4-8c19-e063-6394a90a3cb6	2024-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977 ndc (package): 80425-0419-1 ndc (product): 80425-0419 ndc11 (package): 80425041901
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Camber Pharmaceuticals, Inc.	c18067ba-26ba-40b4-a328-3011710be216	2024-07-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211977 application number: ANDA211977

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
606726	esomeprazole magnesium 20 MG Delayed Release Oral Capsule	PSN	1d8bd104-66d4-8c19-e063-6394a90a3cb6	1
606726	esomeprazole 20 MG Delayed Release Oral Capsule	SCD	1d8bd104-66d4-8c19-e063-6394a90a3cb6	1
606726	esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral Capsule	SY	1d8bd104-66d4-8c19-e063-6394a90a3cb6	1
606726	esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral Capsule	SY	1d8bd104-66d4-8c19-e063-6394a90a3cb6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
80425-0419-1	80425041901	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (80425-0419-1)	2024-07-18	No	No	Current