Esomeprazole magnesium

Product NDC
67877-478
Requested package NDC
67877-478-30
11-digit product format
678770478
Labeler code
67877
Product ID
67877-478_c6b5c112-5f5b-453a-836f-54bac8c7dca9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA208333
Marketing category
ANDA
Marketing start
2017-10-20
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
A208333-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-20
A208333-002ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208333-001AB
A208333-002AB

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 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208333-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-2084e616aacf4f…
2026-09-14 22:38:342026-08A208333-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-2084e616aacf4f…
2026-08-18 06:07:402026-07A208333-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07A208333-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208333-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208333-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208333-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208333-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A208333-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208333-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208333-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208333-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208333-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208333-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208333-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208333-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208333-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208333-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208333-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208333-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208333-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208333-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208333-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A208333-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208333-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208333-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208333-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208333-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208333-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208333-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208333-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-208072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208333-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208333-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-205c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208333-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208333-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-205d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208333-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208333-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-204b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208333-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208333-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-2074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208333-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2017-10-2074a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A208333-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A208333-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A208333-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208333-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208333-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208333-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208333-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208333-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208333-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208333-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208333-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208333-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208333-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208333-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208333-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208333-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208333-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208333-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208333-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208333-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208333-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208333-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208333-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208333-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208333-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208333-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208333-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208333-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208333-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208333-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208333-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A208333-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208333-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208333-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208333-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A208333-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208333-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A208333-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208333-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A208333-002AB174a2ff9319b5…

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 · 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
f3d4a0d7-77fd-496e-8dfa-2b2dbace4bacAvailable 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
67877-478-05Esomeprazole magnesium500 in 1 BOTTLECAPSULE, DELAYED RELEASE50019
67877-478-10Esomeprazole magnesium1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100019
67877-478-30Esomeprazole magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE3019
67877-478-38Esomeprazole magnesium10 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1019
67877-478-38Esomeprazole magnesium10 in 1 CARTONCAPSULE, DELAYED RELEASE1019
67877-478-90Esomeprazole magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-478-10EA - Each67877-478026c966f-0195-4a84-82e0-b67f2b96c5aa12018-09-05
67877-478-30EA - Each67877-478169b16fe-fcd7-406b-8a7d-a574997ea42012018-09-05
67877-478-90EA - Each67877-478ac39fee5-05ba-46d5-ac14-997f62d44a1d12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-478ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [ASCEND LABORATORIES, LLC]19Current NDC, Legacy NDC, 6 package rows20240312_f3d4a0d7-77fd-496e-8dfa-2b2dbace4bac.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMAscend Laboratories, LLCf3d4a0d7-77fd-496e-8dfa-2b2dbace4bac2024-02-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208333
application number: ANDA208333
ndc (package): 67877-478-30
ndc (product): 67877-478
ndc11 (package): 67877047830

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNf3d4a0d7-77fd-496e-8dfa-2b2dbace4bac19
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNf3d4a0d7-77fd-496e-8dfa-2b2dbace4bac19
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDf3d4a0d7-77fd-496e-8dfa-2b2dbace4bac19
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDf3d4a0d7-77fd-496e-8dfa-2b2dbace4bac19
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYf3d4a0d7-77fd-496e-8dfa-2b2dbace4bac19
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYf3d4a0d7-77fd-496e-8dfa-2b2dbace4bac19
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYf3d4a0d7-77fd-496e-8dfa-2b2dbace4bac19
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN8504300f-a584-29ed-e053-2a91aa0ad26c2
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD8504300f-a584-29ed-e053-2a91aa0ad26c2
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY8504300f-a584-29ed-e053-2a91aa0ad26c2
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY8504300f-a584-29ed-e053-2a91aa0ad26c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67877-478-306787704783030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-478-30) 2017-10-200000-00-00NoNoCurrent