esomeprazole magnesium

Product NDC
68788-8524
11-digit product format
687888524
Labeler code
68788
Product ID
68788-8524_efc27899-0425-4367-80ea-3045c6eb59f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA213486
Marketing category
ANDA
Marketing start
2023-09-14
Substance
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
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 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
A213486-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-19
A213486-002ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213486-001AB
A213486-002AB

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 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213486-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-1984e616aacf4f…
2026-09-14 22:38:342026-08A213486-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-1984e616aacf4f…
2026-08-18 06:07:402026-07A213486-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-19caaa826d4ba7…
2026-08-18 06:07:402026-07A213486-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213486-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213486-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213486-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213486-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A213486-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213486-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213486-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213486-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213486-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213486-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213486-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213486-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213486-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213486-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213486-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213486-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213486-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213486-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213486-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-19d06236e962d9…
2024-10-29 15:01 UTC2024-10A213486-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213486-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213486-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213486-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-19301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213486-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213486-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-191e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213486-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213486-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-198072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213486-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213486-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-195c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213486-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213486-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-195d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213486-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213486-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-194b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213486-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-194b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213486-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-19bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213486-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2021-03-19bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A213486-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A213486-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A213486-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213486-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213486-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213486-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213486-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213486-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213486-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213486-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213486-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213486-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213486-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213486-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213486-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213486-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213486-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213486-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213486-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213486-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213486-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213486-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213486-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213486-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213486-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213486-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213486-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213486-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213486-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213486-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213486-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213486-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213486-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213486-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213486-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213486-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213486-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213486-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213486-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213486-002AB1bb7c543d1eb4…

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE MAGNESIUM TRIHYDRATE40 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
2d21ed0b-a089-46f4-9ebb-f24f9f3af61dAvailable 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
68788-8524-1esomeprazole magnesium100 in 1 BOTTLECAPSULE, DELAYED RELEASE1003
68788-8524-2esomeprazole magnesium20 in 1 BOTTLECAPSULE, DELAYED RELEASE203
68788-8524-3esomeprazole magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
68788-8524-6esomeprazole magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE603
68788-8524-9esomeprazole magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8524ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 5 package rows20250502_2d21ed0b-a089-46f4-9ebb-f24f9f3af61d.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 MAGNESIUMREMEDYREPACK INC.e6e1906f-60be-402f-97f4-6d7bea1a6c082026-06-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213486
application number: ANDA213486
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.2d21ed0b-a089-46f4-9ebb-f24f9f3af61d2025-04-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213486
application number: ANDA213486
ndc (product): 68788-8524
ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMQuallent Pharmaceuticals Health LLC7362f930-0879-451e-8de9-8bb8565bfb7e2025-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213486
application number: ANDA213486
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMBiocon Pharma Inc.,66c9e2bf-2dc4-4683-89fd-6dadf1b01ee92025-02-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213486
application number: ANDA213486
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMNuCare Pharmaceuticals,Inc.fe7d7aa8-4f46-83ae-e053-6394a90a01d62025-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213486
application number: ANDA213486
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepackf99f95a2-60e4-4781-80a9-e5b12897dff12024-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213486
application number: ANDA213486
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack2f1b1a56-b6c4-4e30-a1f7-12701aa5a5352024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213486
application number: ANDA213486
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMProficient Rx LP7b92ac4f-50c9-4061-b4a7-535a58cea8f62024-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213486
application number: ANDA213486

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN2d21ed0b-a089-46f4-9ebb-f24f9f3af61d3
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD2d21ed0b-a089-46f4-9ebb-f24f9f3af61d3
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY2d21ed0b-a089-46f4-9ebb-f24f9f3af61d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8524-168788852401100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-1) 2023-09-14NoNoCurrent
68788-8524-26878885240220 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-2) 2023-09-14NoNoCurrent
68788-8524-36878885240330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-3) 2023-09-14NoNoCurrent
68788-8524-66878885240660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-6) 2023-09-14NoNoCurrent
68788-8524-96878885240990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68788-8524-9) 2023-09-14NoNoCurrent