Acid Reducer

Product NDC
69842-679
11-digit product format
698420679
Labeler code
69842
Product ID
69842-679_5f0bc616-6126-4f48-b56c-e8874aed6e90
Type
HUMAN OTC DRUG
Nonproprietary name
Esomeprazole magnesium
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
CVS Pharmacy
Application
ANDA212088
Marketing category
ANDA
Marketing start
2021-12-31
Marketing end
2027-04-30
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
Current FDA listing
Yes

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
A212088-001ESOMEPRAZOLE MAGNESIUMESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25

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
2026-02-19 14:30 UTC2026-02A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-254b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25c0c555d07b60…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A212088-001ESOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORAL2020-06-25a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
Acid Reducer

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
001817ea-906e-47f7-8605-41ba5a9abd21Available 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
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
69842-679-14Acid Reducer14 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE146
69842-679-14Acid Reducer1 in 1 CARTONTABLET, DELAYED RELEASE16
69842-679-42Acid Reducer3 in 1 CARTONTABLET, DELAYED RELEASE36
69842-679-42Acid Reducer14 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE146

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-679ACID REDUCER (ESOMEPRAZOLE MAGNESIUM) TABLET, DELAYED RELEASE [CVS PHARMACY]5Current NDC, Legacy NDC, 4 package rows20230826_001817ea-906e-47f7-8605-41ba5a9abd21.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acid ReducerESOMEPRAZOLE MAGNESIUMWalgreens4f3c1d76-e1ba-4f85-9384-ed8f35fa6bc62026-03-25WarningsExact identifier
application applno (ANDA): 212088
application number: ANDA212088
Acid ReducerESOMEPRAZOLE MAGNESIUMCVS Pharmacy001817ea-906e-47f7-8605-41ba5a9abd212026-01-21WarningsExact identifier
application applno (ANDA): 212088
application number: ANDA212088
ndc (product): 69842-679

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
433733esomeprazole magnesium 20 MG Delayed Release Oral TabletPSN001817ea-906e-47f7-8605-41ba5a9abd216
433733esomeprazole 20 MG Delayed Release Oral TabletSCD001817ea-906e-47f7-8605-41ba5a9abd216
433733esomeprazole 20 MG (as esomeprazole magnesium 22.3 MG) Delayed Release Oral TabletSY001817ea-906e-47f7-8605-41ba5a9abd216

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-679-14698420679141 BOTTLE, PLASTIC in 1 CARTON (69842-679-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2021-12-312027-04-30NoNoCurrent
69842-679-42698420679423 BOTTLE, PLASTIC in 1 CARTON (69842-679-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2021-12-312027-04-30NoNoCurrent