Esomeprazole Magnesium

Product NDC
70518-4581
11-digit product format
705184581
Labeler code
70518
Product ID
70518-4581_4c60d4d3-e06a-6f93-e063-6394a90a16af
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA211977
Marketing category
ANDA
Marketing start
2026-03-06
Substance
ESOMEPRAZOLE MAGNESIUM
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211977-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-02
A211977-002ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211977-001AB
A211977-002AB

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 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211977-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-0284e616aacf4f…
2026-09-14 22:38:342026-08A211977-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-0284e616aacf4f…
2026-08-18 06:07:402026-07A211977-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-02caaa826d4ba7…
2026-08-18 06:07:402026-07A211977-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211977-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211977-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211977-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211977-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A211977-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211977-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211977-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211977-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211977-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211977-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211977-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211977-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211977-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211977-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211977-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211977-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211977-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211977-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211977-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A211977-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211977-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211977-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211977-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211977-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211977-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211977-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211977-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211977-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211977-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211977-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211977-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-025d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211977-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211977-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-024b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211977-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-024b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211977-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-02bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211977-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-06-02bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A211977-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A211977-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A211977-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211977-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211977-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211977-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211977-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211977-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211977-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211977-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211977-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211977-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211977-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211977-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211977-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211977-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211977-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211977-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211977-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211977-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211977-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211977-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211977-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211977-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211977-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211977-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211977-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211977-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211977-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211977-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211977-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211977-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211977-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211977-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211977-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211977-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211977-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211977-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211977-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211977-002AB1bb7c543d1eb4…

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
IngredientStrength
ESOMEPRAZOLE MAGNESIUM40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R6DXU4WAY9Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
ab3d31c8-cab1-4c44-bacd-5e5c67dd1384Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
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
70518-4581-0Esomeprazole Magnesium30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE301

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAmerican Health Packaging9a3df29e-dc44-4dfe-a26f-4bbbf18e31eb2026-08-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211977
application number: ANDA211977
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMREMEDYREPACK INC.ab3d31c8-cab1-4c44-bacd-5e5c67dd13842026-03-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211977
application number: ANDA211977
ndc (product): 70518-4581
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions27e7f7f0-7403-4425-8baa-d12ae93213642026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211977
application number: ANDA211977
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions00aa81c2-73c7-4bf8-94e9-f644381b631f2026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211977
application number: ANDA211977
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAsclemed USA, Inc.2690dbe7-e559-4de8-9582-79b627af19642025-01-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211977
application number: ANDA211977
Esomeprazole DRESOMEPRAZOLE DRDirect_Rxe8937778-8baf-05f5-e053-2995a90a3a982025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211977
application number: ANDA211977
ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMDirect Rxd5f56bd4-3a59-6857-e053-2995a90a6e002025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211977
application number: ANDA211977
Esomeprazole Magnesium DRESOMEPRAZOLE MAGNESIUMAdvanced Rx Pharmacy of Tennessee, LLCfab87a2d-79c8-6045-e053-6394a90a23682024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211977
application number: ANDA211977
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions42b8d3f5-d919-48dd-92e4-ed49488dd6642024-10-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211977
application number: ANDA211977
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack7778bf7c-52f7-44b3-ac2c-e5a25f6967b72024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211977
application number: ANDA211977
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack61cc0020-aab8-42a3-b0a6-93062f382c872024-08-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211977
application number: ANDA211977
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAdvanced Rx of Tennessee, LLC1e92676a-6c59-796d-e063-6294a90aaab42024-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211977
application number: ANDA211977
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAdvanced Rx of Tennessee, LLC1d8bd104-66d4-8c19-e063-6394a90a3cb62024-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211977
application number: ANDA211977
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMCamber Pharmaceuticals, Inc.c18067ba-26ba-40b4-a328-3011710be2162024-07-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211977
application number: ANDA211977

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNab3d31c8-cab1-4c44-bacd-5e5c67dd13841
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDab3d31c8-cab1-4c44-bacd-5e5c67dd13841
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYab3d31c8-cab1-4c44-bacd-5e5c67dd13841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4581-07051845810030 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-4581-0) 2026-03-06NoNoCurrent