Esomeprazole Magnesium

Product NDC
72789-352
11-digit product format
727890352
Labeler code
72789
Product ID
72789-352_38063934-d3b6-c6af-e063-6294a90a853c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA205606
Marketing category
ANDA
Marketing start
2016-04-21
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
A205606-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21
A205606-002ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205606-001AB
A205606-002AB

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 UTC2026-02A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-2103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-212680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-215bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21d06236e962d9…
2024-10-29 15:01 UTC2024-10A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-2179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-211e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-218072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-215c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-215d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-214b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-2174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205606-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21782e0a99824c…
2021-12-28 21:50 UTC2021-12A205606-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2016-04-21782e0a99824c…

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 UTC2026-02A205606-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205606-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205606-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205606-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205606-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205606-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205606-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205606-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205606-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205606-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205606-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205606-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205606-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205606-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205606-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205606-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205606-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205606-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205606-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A205606-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205606-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205606-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205606-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205606-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205606-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205606-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205606-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A205606-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205606-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A205606-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A205606-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A205606-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A205606-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A205606-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A205606-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A205606-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A205606-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A205606-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A205606-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A205606-002AB1782e0a99824c…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
606726Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ac12cd05-10cf-4694-a9e8-e5f04fe162a7Available 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
72789-352-30Esomeprazole Magnesium30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE3017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-352ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]16Current NDC, 1 package rows20250124_ac12cd05-10cf-4694-a9e8-e5f04fe162a7.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions71a4fa85-032b-4f50-a2ee-fd9642ae8b152026-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205606
application number: ANDA205606
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions6ad71713-39da-460b-81fc-e5fba103b2152026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205606
application number: ANDA205606
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMNCS HealthCare of KY, LLC dba Vangard Labs28fbfa02-6c7b-4eb1-af24-86825e6523262026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205606
application number: ANDA205606
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMPD-Rx Pharmaceuticals, Inc.ac12cd05-10cf-4694-a9e8-e5f04fe162a72025-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205606
application number: ANDA205606
ndc (product): 72789-352
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAurobindo Pharma Limited7038a0bc-99b2-4a6e-9b9a-0646ec1877062025-04-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205606
application number: ANDA205606
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAurobindo Pharma Limitedf4ae091d-9b74-4a0e-ac68-057effd91e172025-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205606
application number: ANDA205606
Esomeprazole Magnesium DRESOMEPRAZOLE MAGNESIUMAdvanced Rx Pharmacy of Tennessee, LLCb4cd8ed1-d9d1-5b57-e053-2995a90a9f3c2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205606
application number: ANDA205606
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack009794ae-8199-4176-9dc6-4c5e752d845c2024-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205606
application number: ANDA205606

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNac12cd05-10cf-4694-a9e8-e5f04fe162a717
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDac12cd05-10cf-4694-a9e8-e5f04fe162a717
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYac12cd05-10cf-4694-a9e8-e5f04fe162a717
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYac12cd05-10cf-4694-a9e8-e5f04fe162a717

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72789-352-307278903523030 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-352-30) 2023-10-09NoNoCurrent