esomeprazole magnesium

Product NDC
70771-1494
11-digit product format
707711494
Labeler code
70771
Product ID
70771-1494_7452a5f1-8acc-4d3b-a69f-c9b73d97f09b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA206296
Marketing category
ANDA
Marketing start
2019-05-30
Substance
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
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
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
A206296-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-22
A206296-002ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206296-001AB
A206296-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206296-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206296-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206296-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206296-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A206296-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206296-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206296-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206296-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206296-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206296-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206296-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206296-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206296-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206296-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206296-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206296-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206296-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206296-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206296-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A206296-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206296-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206296-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206296-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206296-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206296-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206296-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206296-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206296-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206296-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206296-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206296-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206296-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206296-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206296-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206296-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206296-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206296-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206296-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206296-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-22782e0a99824c…
2021-12-28 21:50 UTC2021-12A206296-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-22782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206296-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206296-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206296-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206296-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206296-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206296-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206296-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206296-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206296-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206296-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206296-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206296-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206296-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206296-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206296-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206296-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206296-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206296-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206296-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A206296-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206296-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206296-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206296-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206296-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206296-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206296-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206296-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A206296-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206296-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206296-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206296-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A206296-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206296-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A206296-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206296-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A206296-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206296-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A206296-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206296-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A206296-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM DIHYDRATE40 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
606726Internal RxNorm lookup
606730Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6f314f5d-453c-4876-b9b8-20663008dfb1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70771-1494-0esomeprazole magnesium1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10006
70771-1494-3esomeprazole magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE306
70771-1494-9esomeprazole magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1494ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [ZYDUS LIFESCIENCES LIMITED]6Current NDC, Legacy NDC, 3 package rows20241201_6f314f5d-453c-4876-b9b8-20663008dfb1.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMZydus Lifesciences Limited6f314f5d-453c-4876-b9b8-20663008dfb12024-11-28Exact identifier
application applno (ANDA): 206296
application number: ANDA206296
ndc (product): 70771-1494
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMZydus Pharmaceuticals USA Inc.c4b0571e-7b09-441b-90be-bc653806812b2024-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206296
application number: ANDA206296
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack925cee78-83af-480f-838d-8ba97ac6b1e32024-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206296
application number: ANDA206296
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack596e1cf8-dc6e-48b0-95ae-b463955870f72024-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206296
application number: ANDA206296

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN6f314f5d-453c-4876-b9b8-20663008dfb16
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN6f314f5d-453c-4876-b9b8-20663008dfb16
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD6f314f5d-453c-4876-b9b8-20663008dfb16
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD6f314f5d-453c-4876-b9b8-20663008dfb16
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY6f314f5d-453c-4876-b9b8-20663008dfb16
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY6f314f5d-453c-4876-b9b8-20663008dfb16
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY6f314f5d-453c-4876-b9b8-20663008dfb16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70771-1494-0707711494001000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70771-1494-0) 2019-05-300000-00-00NoNoCurrent
70771-1494-37077114940330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70771-1494-3) 2019-05-300000-00-00NoNoCurrent
70771-1494-97077114940990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70771-1494-9) 2019-05-300000-00-00NoNoCurrent