Esomeprazole Magnesium

Product NDC
63187-964
11-digit product format
631870964
Labeler code
63187
Product ID
63187-964_5d8ef640-33d7-451f-af54-2413337b92ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078279
Marketing category
ANDA
Marketing start
2015-12-10
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 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
A078279-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25
A078279-002ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078279-001AB
A078279-002AB

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 UTC2026-02A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25d06236e962d9…
2024-10-29 15:01 UTC2024-10A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-2579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-251e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-258072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-255c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-255d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-254b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-2574a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078279-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25782e0a99824c…
2021-12-28 21:50 UTC2021-12A078279-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2015-09-25782e0a99824c…

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 UTC2026-02A078279-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078279-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078279-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078279-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078279-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078279-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078279-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078279-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078279-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078279-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078279-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078279-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078279-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078279-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078279-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078279-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078279-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078279-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078279-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A078279-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078279-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078279-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078279-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078279-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078279-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078279-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078279-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A078279-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078279-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078279-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078279-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A078279-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078279-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A078279-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078279-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A078279-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078279-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A078279-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078279-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A078279-002AB1782e0a99824c…

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 · 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
e5540d90-0b6e-4519-9272-c6e96730967bAvailable 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
63187-964-30Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE306
63187-964-60Esomeprazole Magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE606
63187-964-90Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-964-30EA - Each63187-964d2b1370d-1393-4c89-9cc5-cac33e00813412023-08-08
63187-964-60EA - Each63187-964d77e45bf-6a74-434b-8ca1-d34b1d6d5f6b12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-964ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]6Current NDC, Legacy NDC, 3 package rows20230204_e5540d90-0b6e-4519-9272-c6e96730967b.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.a9d05a38-08db-4710-b6f3-20c92ce885d52026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMAvPAK4db9f4b8-b6df-f6e9-e063-6294a90a9f602026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMNuCare Pharmaceuticals, Inc.463c9b3b-dd6b-7ee7-e063-6394a90afb432025-12-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMPD-Rx Pharmaceuticals, Inc.fdea1f5f-b717-4d49-8d70-0b373c959bf02025-10-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMNuCare Pharmaceuticals,Inc.2879c79f-bf2a-0bc9-e063-6394a90a98ae2025-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMMajor Pharmaceuticalsba65c73d-fc7d-491e-aaaa-cf45a77833952025-01-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMMedsource Pharmaceuticals1278cf6f-cc7a-462b-e063-6394a90a34e52024-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions71956762-d2f7-4763-9afe-1ca8f32a3cbb2023-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions99fceec8-59a2-485f-a7f3-7c5afd98401d2023-12-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Inc15023261-51c8-2388-3439-48dace49ec022023-07-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMNorthStar Rx LLC380da8db-bfa3-8c0c-f8f3-573675fed9812023-07-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMProficient Rx LPe5540d90-0b6e-4519-9272-c6e96730967b2023-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279
ndc (product): 63187-964
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMProficient Rx LP9224142a-6e14-4ca3-9e72-506ff9fbd0e12022-07-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078279
application number: ANDA078279

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNe5540d90-0b6e-4519-9272-c6e96730967b6
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDe5540d90-0b6e-4519-9272-c6e96730967b6
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYe5540d90-0b6e-4519-9272-c6e96730967b6
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYe5540d90-0b6e-4519-9272-c6e96730967b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-964-306318709643030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-964-30) 2018-01-010000-00-00NoNoCurrent
63187-964-606318709646060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-964-60) 2018-01-010000-00-00NoNoCurrent
63187-964-906318709649090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-964-90) 2018-01-010000-00-00NoNoCurrent