Esomeprazole magnesium

Product NDC
69097-528
11-digit product format
690970528
Labeler code
69097
Product ID
69097-528_e64d9eeb-1821-4520-9325-8b006fec057f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
FOR SUSPENSION
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA211751
Marketing category
ANDA
Marketing start
2020-03-24
Substance
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
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 1.

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
A211751-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-23
A211751-002ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211751-001AB
A211751-002AB

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 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211751-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211751-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-23011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211751-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-2331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211751-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-2331067a03dcf5…
2025-08-23 18:47 UTC2025-08A211751-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-236a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211751-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-236a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211751-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-23fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211751-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-23fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211751-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-23b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211751-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-23b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211751-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-2303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211751-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211751-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-232680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211751-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211751-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-235bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211751-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211751-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-23d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211751-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211751-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-23d06236e962d9…
2024-10-29 15:01 UTC2024-10A211751-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211751-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-2379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211751-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211751-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-23301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211751-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211751-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-231e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211751-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211751-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-238072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211751-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-238072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211751-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-235c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211751-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-235c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211751-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-235d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211751-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-235d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211751-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-234b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211751-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-234b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211751-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-23bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211751-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-23bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211751-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-23782e0a99824c…
2021-12-28 21:50 UTC2021-12A211751-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-23782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211751-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-2387673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211751-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASE/PACKETFOR SUSPENSION, DELAYED RELEASE / ORALAB2020-03-2387673890dc5c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211751-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211751-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211751-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211751-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211751-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211751-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211751-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211751-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211751-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211751-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211751-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211751-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211751-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211751-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211751-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211751-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211751-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211751-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211751-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211751-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211751-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211751-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211751-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211751-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211751-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211751-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211751-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211751-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211751-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211751-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211751-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211751-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211751-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211751-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211751-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211751-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211751-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A211751-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211751-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211751-002AB187673890dc5c…

Additional Listing Data#

Finished product
Yes
Brand name base
Esomeprazole magnesium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
36H71644EQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
692576Internal RxNorm lookup
692578Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c1319da6-bf0d-4dd6-a713-1677bfbfbdaeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d4880ace-a516-8c47-8dfd-73a4ba5887d7Product name220180830
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-528-34Esomeprazole magnesium30 in 1 CARTONFOR SUSPENSION307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-528-34EA - Each69097-5280ffcfe6a-eab7-4f72-91ee-555d1866dc2412020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-528ESOMEPRAZOLE MAGNESIUM FOR SUSPENSION [CIPLA USA INC.]7Current NDC, Legacy NDC, 1 package rows20240517_c1319da6-bf0d-4dd6-a713-1677bfbfbdae.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMCipla USA Inc.c1319da6-bf0d-4dd6-a713-1677bfbfbdae2024-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211751
application number: ANDA211751
ndc (product): 69097-528

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
692576esomeprazole 20 MG Granules for Delayed Release Oral SuspensionPSNc1319da6-bf0d-4dd6-a713-1677bfbfbdae7
692578esomeprazole 40 MG Granules for Delayed Release Oral SuspensionPSNc1319da6-bf0d-4dd6-a713-1677bfbfbdae7
692576esomeprazole 20 MG Granules for Oral SuspensionSCDc1319da6-bf0d-4dd6-a713-1677bfbfbdae7
692578esomeprazole 40 MG Granules for Oral SuspensionSCDc1319da6-bf0d-4dd6-a713-1677bfbfbdae7
692576esomeprazole (as esomeprazole magnesium) 20 MG Granules for Delayed Release Oral SuspensionSYc1319da6-bf0d-4dd6-a713-1677bfbfbdae7
692576esomeprazole 20 MG Granules for Delayed Release Oral SuspensionSYc1319da6-bf0d-4dd6-a713-1677bfbfbdae7
692578esomeprazole 40 MG (equivalent to esomeprazole magnesium 44.5 MG) Granules for Delayed Release Oral SuspensionSYc1319da6-bf0d-4dd6-a713-1677bfbfbdae7
692578esomeprazole 40 MG Granules for Delayed Release Oral SuspensionSYc1319da6-bf0d-4dd6-a713-1677bfbfbdae7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-528-346909705283430 FOR SUSPENSION in 1 CARTON (69097-528-34) 30 for suspension2020-03-240000-00-00NoNoCurrent