ESOMEPRAZOLE MAGNESIUM for delayed-release oral suspension

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-11-28
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 21:18:23

Label at a glance#

ProductEsomeprazole Magnesium
Active ingredientESOMEPRAZOLE MAGNESIUM DIHYDRATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Esomeprazole Magnesium For Delayed-Release Oral Suspension

NDC 70771-1391-1

20 mg packet

Rx Only

20 mg packet
20 mg packet

Esomeprazole Magnesium For Delayed-Release Oral Suspension

NDC 70771-1391-3 unit dose packages of 30: 20 mg packets

Rx Only

20 mg carton
20 mg carton

Esomeprazole Magnesium For Delayed-Release Oral Suspension

NDC 70771-1392-1

40 mg packet

Rx Only

40 mg packet
40 mg packet

Esomeprazole Magnesium For Delayed-Release Oral Suspension

NDC 70771-1392-3 unit dose packages of 30: 40 mg packets

Rx Only

40 mg carton
40 mg carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
692576esomeprazole 20 MG Granules for Delayed Release Oral SuspensionPSN2
692578esomeprazole 40 MG Granules for Delayed Release Oral SuspensionPSN2
692576esomeprazole 20 MG Granules for Oral SuspensionSCD2
692578esomeprazole 40 MG Granules for Oral SuspensionSCD2
692576esomeprazole (as esomeprazole magnesium) 20 MG Granules for Delayed Release Oral SuspensionSY2
692576esomeprazole 20 MG Granules for Delayed Release Oral SuspensionSY2
692578esomeprazole 40 MG (equivalent to esomeprazole magnesium 44.5 MG) Granules for Delayed Release Oral SuspensionSY2
692578esomeprazole 40 MG Granules for Delayed Release Oral SuspensionSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ESOMEPRAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1391-3Esomeprazole Magnesium30 in 1 CARTONGRANULE, DELAYED RELEASE302
70771-1392-3Esomeprazole Magnesium30 in 1 CARTONGRANULE, DELAYED RELEASE302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1391ESOMEPRAZOLE MAGNESIUM GRANULE, DELAYED RELEASE [ZYDUS LIFESCIENCES LIMITED]2Current NDC, 1 package rows20241201_4cd9e802-c519-4593-bc38-947ad7f9b567.zip
70771-1392ESOMEPRAZOLE MAGNESIUM GRANULE, DELAYED RELEASE [ZYDUS LIFESCIENCES LIMITED]2Current NDC, 1 package rows20241201_4cd9e802-c519-4593-bc38-947ad7f9b567.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-139170771-1391-3
70771-139270771-1392-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206055-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-07
A206055-002ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206055-001AB
A206055-002AB

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 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A206055-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-07c2088c7a36db…
2026-10-15 13:18:302026-09A206055-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-07c2088c7a36db…
2026-09-14 22:38:342026-08A206055-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-0784e616aacf4f…
2026-09-14 22:38:342026-08A206055-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-0784e616aacf4f…
2026-08-18 06:07:402026-07A206055-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-07caaa826d4ba7…
2026-08-18 06:07:402026-07A206055-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206055-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206055-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206055-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206055-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A206055-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206055-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206055-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206055-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206055-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206055-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206055-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206055-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206055-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206055-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206055-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206055-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206055-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206055-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206055-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A206055-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206055-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206055-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206055-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206055-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206055-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206055-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206055-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206055-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-078072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206055-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-076a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206055-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206055-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-071c564ffb4f44…
2024-02-18 07:12 UTC2024-02A206055-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206055-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-07ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A206055-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2023-06-07ea1830bbd6c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A206055-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A206055-002AB1c2088c7a36db…
2026-09-14 22:38:342026-08A206055-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A206055-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A206055-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206055-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206055-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206055-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206055-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206055-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206055-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206055-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206055-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206055-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206055-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206055-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206055-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206055-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206055-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206055-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206055-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206055-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206055-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206055-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206055-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206055-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206055-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206055-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206055-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206055-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206055-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206055-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206055-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206055-002AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206055-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206055-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206055-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A206055-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206055-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A206055-002AB1ea1830bbd6c7…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMZydus Lifesciences Limited4cd9e802-c519-4593-bc38-947ad7f9b5672024-11-28Exact identifier
ndc (package): 70771-1391-3
ndc (package): 70771-1392-3
ndc (product): 70771-1391
ndc (product): 70771-1392
ndc11 (package): 70771139103
ndc11 (package): 70771139203
spl id: 983313a8-2120-4c76-8412-0c0c6a159465
spl set id: 4cd9e802-c519-4593-bc38-947ad7f9b567

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.