signature care esomeprazole magnesium

Product NDC
21130-714
11-digit product format
211300714
Labeler code
21130
Product ID
21130-714_f00018f1-772f-4ac0-a1fe-41c1f59c15f0
Type
HUMAN OTC DRUG
Nonproprietary name
esomeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Safeway
Application
ANDA207193
Marketing category
ANDA
Marketing start
2020-07-02
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage21130-71421130-714-01DDiscontinued by firm2026-08-03

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
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
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…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-09-29 23:25 UTC2022-09A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207193-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2017-08-18cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
signature care esomeprazole magnesium
Listing expiration
2026-12-31

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
972bb479-7146-454d-ace4-f9314f0e584eAvailable 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
21130-714-01signature care esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
21130-714-01signature care esomeprazole magnesium1 in 1 CARTONCAPSULE, DELAYED RELEASE13
21130-714-03signature care esomeprazole magnesium3 in 1 CARTONCAPSULE, DELAYED RELEASE33
21130-714-03signature care esomeprazole magnesium14 in 1 BOTTLECAPSULE, DELAYED RELEASE143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-714SIGNATURE CARE ESOMEPRAZOLE MAGNESIUM (ESOMEPRAZOLE) CAPSULE, DELAYED RELEASE [SAFEWAY]3Current NDC, Legacy NDC, 4 package rows20240806_972bb479-7146-454d-ace4-f9314f0e584e.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 3 · 41 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ESOMEPRAZOLE MAGNESIUM MINISESOMEPRAZOLE MAGNESIUM DIHYDRATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDc1435a38-b816-45a1-a0f6-4ad0c5b6da582026-07-27WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
esomeprazole magnesiumESOMEPRAZOLERite Aid Corporation6996642f-a63e-4be9-aefd-0634e9914c2b2026-07-07WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
Basic Care Esomeprazole MagnesiumESOMEPRAZOLEAmazon.com Services LLC42dd2e93-776c-4f49-b590-afc7dab6ef2f2026-06-17WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
good sense esomeprazole magnesiumESOMEPRAZOLEL. Perrigo Companyf13088de-6841-453e-acb0-08bbdf9529d12026-05-20WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
esomeprazole magnesiumESOMEPRAZOLE MAGNESIUM DIHYDRATEHyVee Incc2308fc8-1549-476d-9769-2991051360ad2026-03-24WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
EQUATE ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLEWALMART INC.ce5f2915-327d-4a91-b7fd-e399664a250f2026-03-19WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
Foster and Thrive Acid ReducerESOMEPRAZOLEStrategic Sourcing Services LLC32933772-c0ef-46ad-84e5-d70218bcc8662026-03-07WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUM DIHYDRATEWalgreen Company29eb7b87-59a4-4d27-ad53-789da7fec4272026-02-28WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
members mark esomeprazole magnesiumESOMEPRAZOLESam's West Inc87913038-4b90-40a0-bce5-2d368bd5758c2026-02-07WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
esomeprazole magnesiumESOMEPRAZOLEHyVee Incb0968243-171e-428a-b692-740e0c05a0fc2026-01-29WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
equate esomeprazole magnesiumESOMEPRAZOLEWal-Mart Stores Incaaafc536-f846-4019-a629-b52b3f36e6822026-01-19WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
berkley and jensen heartburn treatmentESOMEPRAZOLEBJWC2369c948-d46f-4ace-bc51-47477631bc432026-01-19WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
careone esomeprazole magnesiumESOMEPRAZOLEAmerican Sales Company3f9a2747-8afd-4898-bbfb-5f379293137e2025-11-03WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
Esomeprazole MagnesiumESOMEPRAZOLEPublix Super Markets Inc60554fd6-96d5-4e73-b676-332116caa8002025-09-29WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
equate esomeprazole magnesiumESOMEPRAZOLE MAGNESIUM DIHYDRATEWALMART INC.2d40c4bf-5b66-420c-9f17-3f31edc40d1a2025-09-11WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
Up and Up Esomeprazole MagnesiumESOMEPRAZOLE MAGNESIUMTarget Corporationb3d3ad1d-96f8-4f72-ae66-f14940a628822025-06-02WarningsExact identifier
application applno (ANDA): 207193
application number: ANDA207193
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
606726esomeprazole magnesium 20 MG Delayed Release Oral CapsulePSN972bb479-7146-454d-ace4-f9314f0e584e3
606726esomeprazole 20 MG Delayed Release Oral CapsuleSCD972bb479-7146-454d-ace4-f9314f0e584e3
606726esomeprazole 20 MG (as esomeprazole magnesium dihydrate 22 MG) Delayed Release Oral CapsuleSY972bb479-7146-454d-ace4-f9314f0e584e3
606726esomeprazole 20 MG (as esomeprazole magnesium trihydrate 22.3 MG) Delayed Release Oral CapsuleSY972bb479-7146-454d-ace4-f9314f0e584e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-714-01211300714011 BOTTLE in 1 CARTON (21130-714-01) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2020-07-020000-00-00NoNoCurrent
21130-714-03211300714033 BOTTLE in 1 CARTON (21130-714-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2020-07-020000-00-00NoNoCurrent