basic care omeprazole

Product NDC
72288-023
11-digit product format
722880023
Labeler code
72288
Product ID
72288-023_51fc32a9-aa60-4835-a89b-1d28cb421a84
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA216096
Marketing category
ANDA
Marketing start
2023-02-22
Substance
OMEPRAZOLE 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

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
A216096-001OMEPRAZOLE MAGNESIUMOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-24

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
2026-08-01 22:54:322026-06A216096-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORAL2022-05-24a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GOOD SENSE OMEPRAZOLEOMEPRAZOLEL. Perrigo Companyb840439b-540b-465a-8faa-f7b1024c628e2026-06-29WarningsExact identifier
application applno (ANDA): 216096
application number: ANDA216096
OMEPRAZOLEOMEPRAZOLESafewayb3ec4a44-5643-4438-b41b-e049464367192026-05-18WarningsExact identifier
application applno (ANDA): 216096
application number: ANDA216096
omeprazoleOMEPRAZOLEAmazon.com Services LLC7e0d319c-6917-45c4-b7e1-e870fc3fcea52026-05-13WarningsExact identifier
application applno (ANDA): 216096
application number: ANDA216096
OMEPRAZOLEOMEPRAZOLECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED6479415a-ffb0-4d20-ad00-f091c8aaaadb2026-03-31WarningsExact identifier
application applno (ANDA): 216096
application number: ANDA216096
OMEPRAZOLEOMEPRAZOLEWalgreen Company97eaf0dc-380b-4039-aeb7-dde39942a9d62026-03-31WarningsExact identifier
application applno (ANDA): 216096
application number: ANDA216096
omeprazoleOMEPRAZOLEMeijer, Inc.47c41c68-cb20-40f0-9d85-ea8db33284782026-03-06WarningsExact identifier
application applno (ANDA): 216096
application number: ANDA216096
omeprazoleOMEPRAZOLE MAGNESIUMCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED8edfcc08-a14e-4579-bd44-045267de5b792025-04-02WarningsExact identifier
application applno (ANDA): 216096
application number: ANDA216096
equate omeprazoleOMEPRAZOLE MAGNESIUMWALMART INC.6790b6c8-c258-4dfb-a400-25dc2812971f2025-03-26WarningsExact identifier
application applno (ANDA): 216096
application number: ANDA216096
basic care omeprazoleOMEPRAZOLE MAGNESIUMAmazon.com Services LLCa4627be3-9845-428d-b3b1-c3096ae3d9b42024-09-05WarningsExact identifier
application applno (ANDA): 216096
application number: ANDA216096
ndc (product): 72288-023
omeprazoleOMEPRAZOLE MAGNESIUMSafeway7ae4d70f-08f1-4586-965f-5a32fbe215912024-06-04WarningsExact identifier
application applno (ANDA): 216096
application number: ANDA216096
omeprazoleOMEPRAZOLE MAGNESIUMWalgreen Companyf56ff74d-116d-4a75-87dc-41c309f039182024-04-15WarningsExact identifier
application applno (ANDA): 216096
application number: ANDA216096
omeprazoleOMEPRAZOLE MAGNESIUMMeijer, Inc.0340ef94-d2b4-47af-a045-d0d0312939842024-03-29WarningsExact identifier
application applno (ANDA): 216096
application number: ANDA216096

Additional Listing Data#

Finished product
Yes
Brand name base
basic care omeprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE MAGNESIUM20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
426QFE7XLKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198051Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a4627be3-9845-428d-b3b1-c3096ae3d9b4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-023-01basic care omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
72288-023-03basic care omeprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-023BASIC CARE OMEPRAZOLE (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [AMAZON.COM SERVICES LLC]3Current NDC, 2 package rows20240912_a4627be3-9845-428d-b3b1-c3096ae3d9b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNa4627be3-9845-428d-b3b1-c3096ae3d9b43
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDa4627be3-9845-428d-b3b1-c3096ae3d9b43
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYa4627be3-9845-428d-b3b1-c3096ae3d9b43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72288-023-017228800230114 in 1 BOTTLEHistorical
72288-023-03722880023033 BOTTLE in 1 CARTON (72288-023-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72288-023-01) 3 bottle2023-02-22NoNoCurrent