Esomeprazole magnesium

Product NDC
63304-734
Requested package NDC
63304-734-10
11-digit product format
633040734
Labeler code
63304
Product ID
63304-734_6d8e57e7-6cc5-4edc-8a4e-47ab7fdae397
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc
Application
ANDA209735
Marketing category
ANDA
Marketing start
2025-09-18
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…

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
A209735-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-30
A209735-002ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A209735-001AB
A209735-002AB

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 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A209735-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-30caaa826d4ba7…
2026-08-18 06:07:402026-07A209735-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209735-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209735-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209735-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209735-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A209735-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209735-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209735-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2018-04-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209735-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORAL2018-04-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209735-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2018-04-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209735-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORAL2018-04-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209735-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2018-04-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209735-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORAL2018-04-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209735-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORAL2018-04-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209735-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORAL2018-04-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209735-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209735-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209735-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209735-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209735-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A209735-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209735-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209735-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209735-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209735-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209735-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209735-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209735-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209735-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209735-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209735-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209735-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209735-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209735-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209735-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209735-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-3074a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209735-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209735-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209735-002ESOMEPRAZOLE MAGNESIUMEQ 40MG BASECAPSULE, DELAYED REL PELLETS / ORALAB2018-04-30bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A209735-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209735-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A209735-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A209735-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209735-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209735-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209735-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A209735-002AB16a471c1ec25d…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209735-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209735-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209735-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209735-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209735-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A209735-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209735-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209735-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209735-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209735-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209735-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209735-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209735-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A209735-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209735-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209735-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209735-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A209735-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209735-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A209735-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209735-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A209735-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209735-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A209735-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209735-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A209735-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209735-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209735-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A209735-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A209735-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209735-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A209735-002AB18869cabd3fbd…

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
dc85d0c8-d3c4-4d37-9a5b-8f5f992bb3bfAvailable 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
63304-734-10Esomeprazole magnesium1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10008
63304-734-30Esomeprazole magnesium30 in 1 BOTTLECAPSULE, DELAYED RELEASE308
63304-734-90Esomeprazole magnesium90 in 1 BOTTLECAPSULE, DELAYED RELEASE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63304-734-10EA - Each63304-73473a9741c-a17e-42ee-8589-275de8d1c55f12019-06-19
63304-734-30EA - Each63304-734bcc03cd1-5caa-4255-aa0f-e92a720334a212019-06-19
63304-734-90EA - Each63304-7348908bf4a-ebaa-4db7-99d6-dcc975ffe0eb12019-06-19

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMGolden State Medical Supply, Inc.43cf2754-3ec7-75f7-e063-6394a90adfeb2025-11-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209735
application number: ANDA209735
Esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMSun Pharmaceutical Industries, Incdc85d0c8-d3c4-4d37-9a5b-8f5f992bb3bf2025-09-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209735
application number: ANDA209735
ndc (package): 63304-734-10
ndc (product): 63304-734
ndc11 (package): 63304073410

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNdc85d0c8-d3c4-4d37-9a5b-8f5f992bb3bf8
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSNdc85d0c8-d3c4-4d37-9a5b-8f5f992bb3bf8
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDdc85d0c8-d3c4-4d37-9a5b-8f5f992bb3bf8
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCDdc85d0c8-d3c4-4d37-9a5b-8f5f992bb3bf8
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYdc85d0c8-d3c4-4d37-9a5b-8f5f992bb3bf8
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYdc85d0c8-d3c4-4d37-9a5b-8f5f992bb3bf8
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSYdc85d0c8-d3c4-4d37-9a5b-8f5f992bb3bf8
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN6fd71c88-021d-44dd-a6da-80a17461257e3
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD6fd71c88-021d-44dd-a6da-80a17461257e3
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY6fd71c88-021d-44dd-a6da-80a17461257e3
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY6fd71c88-021d-44dd-a6da-80a17461257e3
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN43cf2754-3ec7-75f7-e063-6394a90adfeb1
606730esomeprazole magnesium 40 MG Delayed Release Oral CapsulePSN43cf2754-3ec7-75f7-e063-6394a90adfeb1
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD43cf2754-3ec7-75f7-e063-6394a90adfeb1
606730esomeprazole 40 MG Delayed Release Oral CapsuleSCD43cf2754-3ec7-75f7-e063-6394a90adfeb1
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY43cf2754-3ec7-75f7-e063-6394a90adfeb1
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY43cf2754-3ec7-75f7-e063-6394a90adfeb1
606730esomeprazole 40 MG (as esomeprazole magnesium 44.5 MG) Delayed Release Oral CapsuleSY43cf2754-3ec7-75f7-e063-6394a90adfeb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63304-734-10633040734101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63304-734-10) 2025-09-180000-00-00NoNoCurrent