Esomeprazole Magnesium

Product NDC
68462-390
11-digit product format
684620390
Labeler code
68462
Product ID
68462-390_5eef4592-c7ef-454c-88a9-62671fff9088
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA209495
Marketing category
ANDA
Marketing start
2021-11-01
Substance
ESOMEPRAZOLE MAGNESIUM
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 42.

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
A209495-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2019-05-10
A209495-002ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORAL2019-05-10

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209495-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2019-05-10caaa826d4ba7…
2026-08-18 06:07:402026-07A209495-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORAL2019-05-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209495-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2019-05-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209495-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORAL2019-05-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209495-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2019-05-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209495-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORAL2019-05-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A209495-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2019-05-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209495-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORAL2019-05-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209495-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2019-05-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209495-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORAL2019-05-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209495-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2019-05-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209495-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORAL2019-05-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209495-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2019-05-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209495-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORAL2019-05-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209495-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2019-05-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209495-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORAL2019-05-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209495-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209495-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209495-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2019-05-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209495-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORAL2019-05-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209495-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2019-05-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A209495-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORAL2019-05-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209495-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209495-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209495-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-10301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209495-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209495-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-101e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209495-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209495-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-108072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209495-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209495-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209495-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209495-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209495-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209495-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209495-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209495-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209495-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209495-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209495-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2019-05-10bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 62 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209495-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209495-002AB15bbf6a4d5a75…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209495-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209495-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209495-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209495-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209495-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209495-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209495-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209495-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209495-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209495-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209495-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209495-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209495-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209495-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209495-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209495-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209495-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209495-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209495-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A209495-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209495-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209495-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A209495-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A209495-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209495-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A209495-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209495-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A209495-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209495-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A209495-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A209495-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A209495-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209495-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A209495-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209495-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209495-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209495-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A209495-002AB11c564ffb4f44…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM20 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 · 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
a6430045-ae60-4a16-92b9-2975cb497629Available 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
68462-390-10Esomeprazole Magnesium1000 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS10004
68462-390-30Esomeprazole Magnesium30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS304
68462-390-90Esomeprazole Magnesium90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-390-10EA - Each68462-3904ef150a2-7598-42aa-9381-a92312f5f9bd12022-02-07
68462-390-30EA - Each68462-390eccc0d8c-6f22-42d9-a8a4-4138c8f2bb8c12022-02-07
68462-390-90EA - Each68462-39012323494-0dcb-4578-897d-2c7af94edc8212022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-390ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS [GLENMARK PHARMACEUTICALS INC., USA]4Current NDC, Legacy NDC, 3 package rows20240612_a6430045-ae60-4a16-92b9-2975cb497629.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMGlenmark Pharmaceuticals Inc., USAa6430045-ae60-4a16-92b9-2975cb4976292023-12-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209495
application number: ANDA209495
ndc (product): 68462-390
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutionsdef3f166-e740-41ed-82c0-9b03dd6432b12023-11-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209495
application number: ANDA209495
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutionse79725fe-54c8-4dcb-a03a-0c91cc20cf772023-10-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209495
application number: ANDA209495

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNa6430045-ae60-4a16-92b9-2975cb4976294
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNa6430045-ae60-4a16-92b9-2975cb4976294
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDa6430045-ae60-4a16-92b9-2975cb4976294
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDa6430045-ae60-4a16-92b9-2975cb4976294
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYa6430045-ae60-4a16-92b9-2975cb4976294
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYa6430045-ae60-4a16-92b9-2975cb4976294
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYa6430045-ae60-4a16-92b9-2975cb4976294
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNe79725fe-54c8-4dcb-a03a-0c91cc20cf773
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDe79725fe-54c8-4dcb-a03a-0c91cc20cf773
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYe79725fe-54c8-4dcb-a03a-0c91cc20cf773
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYe79725fe-54c8-4dcb-a03a-0c91cc20cf773

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68462-390-10684620390101000 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-390-10) 2021-11-010000-00-00NoNoCurrent
68462-390-306846203903030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-390-30) 2021-11-010000-00-00NoNoCurrent
68462-390-906846203909090 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (68462-390-90) 2021-11-010000-00-00NoNoCurrent