Esomeprazole Magnesium

Product NDC
75907-119
11-digit product format
759070119
Labeler code
75907
Product ID
75907-119_a40c48e8-93c4-8b65-6b4d-a6d236e39c38
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Dr. Reddys Laboratories Inc
Application
ANDA211571
Marketing category
ANDA
Marketing start
2023-12-30
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct75907-119UNFINISHEDActive or certified unfinished drug listing2026-10-05
unfinished packagepackage75907-11975907-119-24UNFINISHEDActive or certified unfinished drug listing2026-10-05

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 · 28 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage75907-119-24a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage75907-119-241d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage75907-119-24390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage75907-119-24e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage75907-119-24bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage75907-119-24f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage75907-119-24f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage75907-119-2468b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage75907-119-2405c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage75907-119-2448b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage75907-119-2427f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage75907-119-248d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage75907-119-24d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage75907-119-2450b4072663b7…eae3003ed65e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211571-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-1484e616aacf4f…
2026-08-18 06:07:402026-07A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-144b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211571-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-05-14a50c72e98297…

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
433733Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2c2bcdf7-689a-47bd-1713-0ea74f72044bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7006a36-e68d-42e2-8cd3-d725cb2e47b1Product name620251027
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
d71865e8-5c35-4d76-8ecd-a7adda982240Product name920180628
d71865e8-5c35-4d76-8ecd-a7adda982240Product name820171212
094c6751-235c-4d12-acee-2baf94f676f4Product name120151116
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
ce67e27d-1d21-5465-4409-b0662dd99d4dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75907-119-27Esomeprazole Magnesium14 in 1 BOTTLETABLET, DELAYED RELEASE141
75907-119-27Esomeprazole Magnesium2 in 1 CARTONTABLET, DELAYED RELEASE21
75907-119-33Esomeprazole Magnesium14 in 1 BOTTLETABLET, DELAYED RELEASE141
75907-119-33Esomeprazole Magnesium3 in 1 CARTONTABLET, DELAYED RELEASE31
75907-119-52Esomeprazole Magnesium1 in 1 CARTONTABLET, DELAYED RELEASE11
75907-119-52Esomeprazole Magnesium14 in 1 BOTTLETABLET, DELAYED RELEASE141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75907-119ESOMEPRAZOLE MAGNESIUM TABLET, DELAYED RELEASE [DR. REDDYS LABORATORIES INC]1Current NDC, 6 package rows20231230_2c2bcdf7-689a-47bd-1713-0ea74f72044b.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMDr. Reddys Laboratories Incb9605af1-a117-2fea-9f4b-bd4816d804e22025-11-04WarningsExact identifier
application applno (ANDA): 211571
application number: ANDA211571
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMWalgreensf0374954-e84f-ac82-1ace-3bad8628629a2025-11-04WarningsExact identifier
application applno (ANDA): 211571
application number: ANDA211571
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMCVS Pharmacy0b3b2f9b-f7f3-1a32-4e14-f10aecd6aabb2025-08-30WarningsExact identifier
application applno (ANDA): 211571
application number: ANDA211571
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMDr. Reddys Laboratories Inc2c2bcdf7-689a-47bd-1713-0ea74f72044b2023-12-14WarningsExact identifier
application applno (ANDA): 211571
application number: ANDA211571
ndc (product): 75907-119

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433733esomeprazole magnesium 20 MG Delayed Release Oral TabletPSNf0374954-e84f-ac82-1ace-3bad8628629a2
433733esomeprazole 20 MG Delayed Release Oral TabletSCDf0374954-e84f-ac82-1ace-3bad8628629a2
433733esomeprazole 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral TabletSYf0374954-e84f-ac82-1ace-3bad8628629a2
433733esomeprazole magnesium 20 MG Delayed Release Oral TabletPSN0b3b2f9b-f7f3-1a32-4e14-f10aecd6aabb1
433733esomeprazole magnesium 20 MG Delayed Release Oral TabletPSN2c2bcdf7-689a-47bd-1713-0ea74f72044b1
433733esomeprazole 20 MG Delayed Release Oral TabletSCD0b3b2f9b-f7f3-1a32-4e14-f10aecd6aabb1
433733esomeprazole 20 MG Delayed Release Oral TabletSCD2c2bcdf7-689a-47bd-1713-0ea74f72044b1
433733esomeprazole 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral TabletSY0b3b2f9b-f7f3-1a32-4e14-f10aecd6aabb1
433733esomeprazole 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral TabletSY2c2bcdf7-689a-47bd-1713-0ea74f72044b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75907-119-24759070119242400 TABLET, DELAYED RELEASE in 1 POUCH (75907-119-24)01-NOV-23Current
75907-119-27759070119272 BOTTLE in 1 CARTON (75907-119-27) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE2 bottle2023-12-30NoNoCurrent
75907-119-33759070119333 BOTTLE in 1 CARTON (75907-119-33) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2023-12-30NoNoCurrent
75907-119-52759070119521 BOTTLE in 1 CARTON (75907-119-52) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2023-12-30NoNoCurrent