EQUATE ESOMEPRAZOLE MAGNESIUM

Product NDC
79903-419
11-digit product format
799030419
Labeler code
79903
Product ID
79903-419_4adcde28-8101-4dc3-88e6-c78ba95fc746
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
WALMART INC.
Application
ANDA207193
Marketing category
ANDA
Marketing start
2026-03-16
Substance
ESOMEPRAZOLE
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
2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207193-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-1884e616aacf4f…
2026-08-18 06:07:402026-07A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-183f01610625f2…
2019-09-15 20:21 UTC2019-09A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18f41ea6bd6efb…

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
EQUATE ESOMEPRAZOLE MAGNESIUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESOMEPRAZOLE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N3PA6559FTInternal 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
ce5f2915-327d-4a91-b7fd-e399664a250fAvailable 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
79903-419-14EQUATE ESOMEPRAZOLE MAGNESIUM14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
79903-419-42EQUATE ESOMEPRAZOLE MAGNESIUM3 in 1 CARTONCAPSULE, DELAYED RELEASE32

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 2 of 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
leader esomeprazole magnesiumESOMEPRAZOLECardinal Health 110, LLC. dba Leaderc9472b82-d345-4531-bf07-bd55c94876ab2025-04-23WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
esomeprazole magnesiumESOMEPRAZOLECVS Pharmacy6f1d75c1-3c0d-41c2-a625-1ee1bf642c322025-01-11WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
topcare esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMTopco Associates LLC86384845-0bea-490b-b04a-5770ef88b6392024-09-01WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
Good Sense Esomeprazole MagnesiumESOMEPRAZOLEL. Perrigo Company4a89b4b5-5c42-44ee-98a9-e26a237aaef72024-08-27WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMCVS Pharmacydcaaf24a-0fb9-41b9-881a-00fa60796ca92024-08-06WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUMMeijer Distribution Inc1dd30fec-15f4-44b2-a38f-e59ff4da206d2024-08-06WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
DG Health Esomeprazole MagnesiumESOMEPRAZOLEDolgencorp Inc2b0e555d-3ed5-4ec4-82a6-855351c503b32024-08-02WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
dg health esomeprazole magnesiumESOMEPRAZOLEDolgencorp, LLC8f974698-ce9c-4ffb-b77e-9bad2c2ee2a12024-08-01WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
up and up esomeprazole magnesiumESOMEPRAZOLETarget Corporation717e5d5b-4bf7-415e-b259-44056bc96d8b2024-08-01WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
kirkland signature esomeprazole magnesiumESOMEPRAZOLECostco Wholesale Company4a87d5d5-c98b-4dc5-81be-50183342b0472024-08-01WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
Good Neighbor Pharmacy Esomeprazole MagnesiumESOMEPRAZOLEAmerisource Bergenb596055c-98b2-47b1-b174-ae7ad3ba97ee2024-07-30WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
Exchange Select Esomeprazole MagnesiumESOMEPRAZOLEArmy & Air Force Exchange Service5fa9089f-90d1-48b6-bb79-c6171eeeaa032024-07-26WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
signature care esomeprazole magnesiumESOMEPRAZOLESafeway238b27e3-6993-4213-b7eb-062309398d1b2024-07-26WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
good sense esomeprazole magnesiumESOMEPRAZOLEL. Perrigo Companye54f2cc9-1d5f-4f0a-8bcf-bd5b917d98ec2024-07-26WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
signature care esomeprazole magnesiumESOMEPRAZOLESafeway972bb479-7146-454d-ace4-f9314f0e584e2024-07-26WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
basic care esomeprazole magnesiumESOMEPRAZOLEAmazon.com Services LLC0b115351-318c-4bd9-935c-704a09bcdf522024-07-25WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
esomeprazole magnesiumESOMEPRAZOLEKroger Companyda02c079-ed18-4896-896d-0489c8f435542024-07-25WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
esomeprazole magnesiumESOMEPRAZOLEMeijer Distribution Inc126c269b-260d-40f4-879d-169c09251c672024-07-25WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
dg health esomeprazole magnesiumESOMEPRAZOLEDolgencorp Incd5a842f3-d21b-4ddf-87f1-e44daf5cfe052024-05-08WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
esomeprazole magnesiumESOMEPRAZOLEMeijer, Inc.8799c88f-dafb-4be6-b279-a54d916162fe2024-03-25WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSNce5f2915-327d-4a91-b7fd-e399664a250f2
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCDce5f2915-327d-4a91-b7fd-e399664a250f2
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSYce5f2915-327d-4a91-b7fd-e399664a250f2
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSYce5f2915-327d-4a91-b7fd-e399664a250f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
79903-419-147990304191414 in 1 BOTTLEHistorical
79903-419-42799030419423 BOTTLE in 1 CARTON (79903-419-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (79903-419-14) 3 bottle2026-03-16NoNoCurrent