Esomeprazole Magnesium

Product NDC: 59651-805
Requested package NDC: 59651-805-30
11-digit product format: 596510805
Labeler code: 59651
Product ID: 59651-805_e691b51e-2e31-4408-81c4-5afec6f9bbb6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Esomeprazole Magnesium
Dosage form: GRANULE, DELAYED RELEASE
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA218948
Marketing category: ANDA
Marketing start: 2025-04-15
Substance: ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A218948-001	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2025-04-15
A218948-002	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2025-04-15
A218948-003	ESOMEPRAZOLE MAGNESIUM	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2025-04-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A218948-001	AB
A218948-002	AB
A218948-003	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.

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	A218948-001	ESOMEPRAZOLE MAGNESIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2025-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218948-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2025-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218948-003	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2025-04-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218948-001	ESOMEPRAZOLE MAGNESIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2025-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218948-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2025-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218948-003	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2025-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218948-001	ESOMEPRAZOLE MAGNESIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2025-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218948-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2025-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218948-003	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2025-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218948-001	ESOMEPRAZOLE MAGNESIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2025-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218948-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2025-04-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218948-003	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2025-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218948-001	ESOMEPRAZOLE MAGNESIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2025-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218948-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2025-04-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218948-003	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2025-04-15	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218948-001	ESOMEPRAZOLE MAGNESIUM	EQ 5MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2025-04-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218948-002	ESOMEPRAZOLE MAGNESIUM	EQ 20MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2025-04-15	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218948-003	ESOMEPRAZOLE MAGNESIUM	EQ 40MG BASE/PACKET	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2025-04-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A218948-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218948-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A218948-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A218948-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218948-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A218948-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A218948-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218948-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A218948-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218948-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218948-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A218948-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A218948-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218948-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A218948-003	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218948-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218948-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A218948-003	AB	1	`a50c72e98297…`

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 TRIHYDRATE	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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
692576	Internal RxNorm lookup
692578	Internal RxNorm lookup
1297761	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
e691b51e-2e31-4408-81c4-5afec6f9bbb6	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
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
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
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
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
59651-805-30	Esomeprazole Magnesium	30 in 1 CARTON	GRANULE, DELAYED RELEASE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59651-805-30	EA - Each	59651-805	b78d7557-38a1-431f-bccc-ac7802ccd3d9	1	2025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-805	ESOMEPRAZOLE MAGNESIUM GRANULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]	1	Current NDC, 1 package rows	20250426_e691b51e-2e31-4408-81c4-5afec6f9bbb6.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Esomeprazole Magnesium	ESOMEPRAZOLE MAGNESIUM	Aurobindo Pharma Limited	e691b51e-2e31-4408-81c4-5afec6f9bbb6	2025-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 218948 application number: ANDA218948 ndc (package): 59651-805-30 ndc (product): 59651-805 ndc11 (package): 59651080530

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
692576	esomeprazole 20 MG Granules for Delayed Release Oral Suspension	PSN	e691b51e-2e31-4408-81c4-5afec6f9bbb6	1
692578	esomeprazole 40 MG Granules for Delayed Release Oral Suspension	PSN	e691b51e-2e31-4408-81c4-5afec6f9bbb6	1
1297761	esomeprazole 5 MG Granules for Delayed Release Oral Suspension	PSN	e691b51e-2e31-4408-81c4-5afec6f9bbb6	1
692576	esomeprazole 20 MG Granules for Oral Suspension	SCD	e691b51e-2e31-4408-81c4-5afec6f9bbb6	1
692578	esomeprazole 40 MG Granules for Oral Suspension	SCD	e691b51e-2e31-4408-81c4-5afec6f9bbb6	1
1297761	esomeprazole 5 MG Granules for Oral Suspension	SCD	e691b51e-2e31-4408-81c4-5afec6f9bbb6	1
692576	esomeprazole (as esomeprazole magnesium) 20 MG Granules for Delayed Release Oral Suspension	SY	e691b51e-2e31-4408-81c4-5afec6f9bbb6	1
692576	esomeprazole 20 MG Granules for Delayed Release Oral Suspension	SY	e691b51e-2e31-4408-81c4-5afec6f9bbb6	1
692578	esomeprazole 40 MG (equivalent to esomeprazole magnesium 44.5 MG) Granules for Delayed Release Oral Suspension	SY	e691b51e-2e31-4408-81c4-5afec6f9bbb6	1
692578	esomeprazole 40 MG Granules for Delayed Release Oral Suspension	SY	e691b51e-2e31-4408-81c4-5afec6f9bbb6	1
1297761	esomeprazole 5 MG (equivalent to esomeprazole magnesium 5.6 MG) Granules for Delayed Release Oral Suspension	SY	e691b51e-2e31-4408-81c4-5afec6f9bbb6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
59651-805-30	59651080530	30 GRANULE, DELAYED RELEASE in 1 CARTON (59651-805-30)	2025-04-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Esomeprazole Magnesium	Aurobindo Pharma Limited \| APL HEALTHCARE LIMITED	2025-04-16	Human Prescription Drug Label	1