Esomeprazole Magnesium

Product NDC
71335-2505
Requested package NDC
71335-2505-1
11-digit product format
713352505
Labeler code
71335
Product ID
71335-2505_5a4dabd2-94d0-4eea-828d-0fb0534d3074
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA213859
Marketing category
ANDA
Marketing start
2023-08-15
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 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
A213859-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-18
A213859-002ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213859-001AB
A213859-002AB

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 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A213859-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-1884e616aacf4f…
2026-09-14 22:38:342026-08A213859-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-1884e616aacf4f…
2026-08-18 06:07:402026-07A213859-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-18caaa826d4ba7…
2026-08-18 06:07:402026-07A213859-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213859-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213859-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213859-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213859-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A213859-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213859-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213859-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213859-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213859-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213859-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213859-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213859-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213859-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213859-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213859-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213859-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213859-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213859-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213859-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A213859-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213859-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213859-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213859-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213859-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213859-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-181e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213859-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213859-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-188072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213859-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2020-11-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213859-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2020-11-185c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213859-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORAL2020-11-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213859-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2020-11-185d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A213859-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORAL2020-11-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213859-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2020-11-184b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A213859-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORAL2020-11-184b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213859-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2020-11-18bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A213859-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORAL2020-11-18bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 50 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A213859-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A213859-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A213859-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A213859-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213859-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A213859-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213859-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213859-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213859-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A213859-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213859-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213859-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213859-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213859-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213859-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213859-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213859-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213859-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213859-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213859-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213859-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213859-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213859-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A213859-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213859-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213859-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213859-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213859-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213859-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213859-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213859-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A213859-002AB18072bd15b7f6…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213859-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213859-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A213859-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A213859-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213859-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A213859-002AB18869cabd3fbd…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213859-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213859-002AB16a51e52b5d6a…

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 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
3a879cfc-b0a4-48ca-aa6a-b5e9051601aaAvailable 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
71335-2505-1Esomeprazole Magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE302
71335-2505-2Esomeprazole Magnesium10 in 1 BOTTLECAPSULE, DELAYED RELEASE102
71335-2505-3Esomeprazole Magnesium60 in 1 BOTTLECAPSULE, DELAYED RELEASE602
71335-2505-4Esomeprazole Magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE902
71335-2505-5Esomeprazole Magnesium42 in 1 BOTTLECAPSULE, DELAYED RELEASE422
71335-2505-6Esomeprazole Magnesium120 in 1 BOTTLECAPSULE, DELAYED RELEASE1202
71335-2505-7Esomeprazole Magnesium180 in 1 BOTTLECAPSULE, DELAYED RELEASE1802
71335-2505-8Esomeprazole Magnesium20 in 1 BOTTLECAPSULE, DELAYED RELEASE202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2505-3EA - Each71335-25059b1fcf11-983d-468b-8041-866ab837b75d12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2505ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]2Current NDC, 8 package rows20241226_3a879cfc-b0a4-48ca-aa6a-b5e9051601aa.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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack81f5f7d9-14bb-4804-975e-65d96f91785f2026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213859
application number: ANDA213859
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutionsb58bfbdb-939e-456e-827d-068e9d8088402026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213859
application number: ANDA213859
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMA-S Medication Solutions8a8ca4cf-076c-48c9-8613-f5a1bae87a492026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213859
application number: ANDA213859
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMPreferred Pharmaceuticals Inc.e264d9c8-5ba9-49c1-9b27-d6ff9a6a45ba2025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213859
application number: ANDA213859
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMBryant Ranch Prepack3a879cfc-b0a4-48ca-aa6a-b5e9051601aa2024-12-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213859
application number: ANDA213859
ndc (package): 71335-2505-1
ndc (product): 71335-2505
ndc11 (package): 71335250501
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMSomerset Therapeutics, LLC02893318-e394-5a8e-e063-6394a90a885a2024-11-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213859
application number: ANDA213859

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN3a879cfc-b0a4-48ca-aa6a-b5e9051601aa2
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD3a879cfc-b0a4-48ca-aa6a-b5e9051601aa2
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY3a879cfc-b0a4-48ca-aa6a-b5e9051601aa2
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY3a879cfc-b0a4-48ca-aa6a-b5e9051601aa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2505-17133525050130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-2505-1) 2024-12-05NoNoCurrent