Esomeprazole Magnesium

Product NDC
43598-407
11-digit product format
435980407
Labeler code
43598
Product ID
43598-407_1f7dc391-028d-a98f-7cc6-887f293caf06
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Dr. Reddy's Laboratories Inc
Application
ANDA207673
Marketing category
ANDA
Marketing start
2018-05-16
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 productproduct43598-407UNFINISHEDActive or certified unfinished drug listing2026-08-17
unfinished packagepackage43598-40743598-407-94UNFINISHEDActive or certified unfinished drug listing2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A207673-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-153f01610625f2…
2019-09-15 20:21 UTC2019-09A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207673-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2018-05-15e64feba35796…

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
cb8297ad-ce1b-aa31-2488-5a38b2dbc774Available 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
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
43598-407-27Esomeprazole Magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE29
43598-407-27Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE149
43598-407-33Esomeprazole Magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE39
43598-407-33Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE149
43598-407-52Esomeprazole Magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE149
43598-407-52Esomeprazole Magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE19
43598-407-70Esomeprazole Magnesium7 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE79
43598-407-74Esomeprazole Magnesium2 in 1 CARTONCAPSULE, DELAYED RELEASE29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-407-27EA - Each43598-4079265f067-fb45-43ff-b759-271012fed97f12019-11-12
43598-407-33EA - Each43598-407640b1d30-ce63-4ac0-aef0-2ecd0170378f12019-07-02
43598-407-52EA - Each43598-4075369eaf8-6d29-47f8-9d1a-1e2ed4859f0012019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-407ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [DR. REDDY'S LABORATORIES INC]9Current NDC, Legacy NDC, 8 package rows20221014_cb8297ad-ce1b-aa31-2488-5a38b2dbc774.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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMWalgreens Companyf97f8604-9f00-6ed5-ae25-fedc8cf36a5d2025-10-28WarningsExact identifier
application applno (ANDA): 207673
application number: ANDA207673
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMCHAIN DRUG MARKETING ASSOCIATION INCf95053ab-d6c5-ee92-58d1-6f203873f79c2025-10-28WarningsExact identifier
application applno (ANDA): 207673
application number: ANDA207673
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMHEBe3747f1e-01e7-f3cf-499e-c7c3f6d06a302025-10-28WarningsExact identifier
application applno (ANDA): 207673
application number: ANDA207673
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Inc.945beb4b-8a31-d904-8881-1cf8396043472025-10-28WarningsExact identifier
application applno (ANDA): 207673
application number: ANDA207673
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMThe Kroger Co.b4cdf878-61d3-01bd-48c9-4d6f4fbc71df2025-10-28WarningsExact identifier
application applno (ANDA): 207673
application number: ANDA207673
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMDiscount Drug Mart, Inc0d6e66c5-ca6d-5cda-72d7-9350dbd1eba02024-12-16WarningsExact identifier
application applno (ANDA): 207673
application number: ANDA207673
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Inccb8297ad-ce1b-aa31-2488-5a38b2dbc7742022-09-30WarningsExact identifier
application applno (ANDA): 207673
application number: ANDA207673
ndc (product): 43598-407

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNf97f8604-9f00-6ed5-ae25-fedc8cf36a5d11
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDf97f8604-9f00-6ed5-ae25-fedc8cf36a5d11
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYf97f8604-9f00-6ed5-ae25-fedc8cf36a5d11
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYf97f8604-9f00-6ed5-ae25-fedc8cf36a5d11
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNcb8297ad-ce1b-aa31-2488-5a38b2dbc7749
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDcb8297ad-ce1b-aa31-2488-5a38b2dbc7749
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYcb8297ad-ce1b-aa31-2488-5a38b2dbc7749
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYcb8297ad-ce1b-aa31-2488-5a38b2dbc7749
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNb4cdf878-61d3-01bd-48c9-4d6f4fbc71df6
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNf95053ab-d6c5-ee92-58d1-6f203873f79c6
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDf95053ab-d6c5-ee92-58d1-6f203873f79c6
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDb4cdf878-61d3-01bd-48c9-4d6f4fbc71df6
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYb4cdf878-61d3-01bd-48c9-4d6f4fbc71df6
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYf95053ab-d6c5-ee92-58d1-6f203873f79c6
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYb4cdf878-61d3-01bd-48c9-4d6f4fbc71df6
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYf95053ab-d6c5-ee92-58d1-6f203873f79c6
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN945beb4b-8a31-d904-8881-1cf8396043474
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNe3747f1e-01e7-f3cf-499e-c7c3f6d06a304
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDe3747f1e-01e7-f3cf-499e-c7c3f6d06a304
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD945beb4b-8a31-d904-8881-1cf8396043474
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYe3747f1e-01e7-f3cf-499e-c7c3f6d06a304
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY945beb4b-8a31-d904-8881-1cf8396043474
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY945beb4b-8a31-d904-8881-1cf8396043474
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYe3747f1e-01e7-f3cf-499e-c7c3f6d06a304
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN0d6e66c5-ca6d-5cda-72d7-9350dbd1eba02
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD0d6e66c5-ca6d-5cda-72d7-9350dbd1eba02
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY0d6e66c5-ca6d-5cda-72d7-9350dbd1eba02
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY0d6e66c5-ca6d-5cda-72d7-9350dbd1eba02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-407-27435980407272 BOTTLE in 1 CARTON (43598-407-27) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2018-05-160000-00-00NoNoCurrent
43598-407-33435980407333 BOTTLE in 1 CARTON (43598-407-33) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2018-05-160000-00-00NoNoCurrent
43598-407-52435980407521 BOTTLE in 1 CARTON (43598-407-52) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2018-05-160000-00-00NoNoCurrent
43598-407-70435980407707 in 1 BLISTER PACKHistorical
43598-407-74435980407742 BLISTER PACK in 1 CARTON (43598-407-74) / 7 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (43598-407-70) 2 blister pack2018-05-160000-00-00NoNoCurrent
43598-407-94435980407944000 CAPSULE, DELAYED RELEASE in 1 POUCH (43598-407-94)01-JAN-25Current