omeprazole

Product NDC
42507-414
11-digit product format
425070414
Labeler code
42507
Product ID
42507-414_c7e11072-2333-4846-a37b-2b2c3a59a6d0
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
HyVee Inc
Application
NDA022032
Marketing category
NDA
Marketing start
2026-01-28
Substance
OMEPRAZOLE
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 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
N022032-001OMEPRAZOLEOMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022032-001125995652030-01-31Drug product2026-05-11

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 UTC2026-02N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-0403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-042680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-045bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-0479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-041e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-048072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-045c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-045d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-044b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-0474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-0487673890dc5c…
2021-03-12 10:30 UTC2021-03N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-045aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-048869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-043f01610625f2…
2019-09-15 20:21 UTC2019-09N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04b00525d2431f…
2019-07-19 19:46 UTC2019-07N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-046a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-041c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-049b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-043f0d92c62455…
2023-05-13 08:27 UTC2023-05N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04053a50430f4f…
2023-01-26 05:58 UTC2023-01N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-043bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-043a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04cb3db0bc1861…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022032-00190233912025-08-16Drug product2015-06-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08N022032-00190233912025-08-16Drug product2015-06-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022032-00190233912025-08-16Drug product2015-06-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022032-00190233912025-08-16Drug product2015-06-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022032-00190233912025-08-16Drug product2015-06-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022032-00190233912025-08-16Drug product2015-06-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022032-00190233912025-08-16Drug product2015-06-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022032-00190233912025-08-16Drug product2015-06-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022032-00190233912025-08-16Drug product2015-06-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022032-00190233912025-08-16Drug product2015-06-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022032-00190233912025-08-16Drug product2015-06-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022032-00190233912025-08-16Drug product2015-06-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022032-00190233912025-08-16Drug product2015-06-038072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022032-00190233912025-08-16Drug product2015-06-035c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022032-00190233912025-08-16Drug product2015-06-035d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022032-00190233912025-08-16Drug product2015-06-034b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022032-00190233912025-08-16Drug product2015-06-0374a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022032-00190233912025-08-16Drug product2015-06-03bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022032-00190233912025-08-16Drug product2015-06-03782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022032-00190233912025-08-16Drug product2015-06-0387673890dc5c…
2021-03-12 10:30 UTC2021-03N022032-00190233912025-08-16Drug product2015-06-035aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022032-00190233912025-08-16Drug product2015-06-038869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022032-00190233912025-08-16Drug product2015-06-03c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022032-00190233912025-08-16Drug product2015-06-033f01610625f2…
2019-09-15 20:21 UTC2019-09N022032-00190233912025-08-16Drug product2015-06-03b00525d2431f…
2019-07-19 19:46 UTC2019-07N022032-00190233912025-08-16Drug product2015-06-03ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022032-00190233912025-08-16Drug product2015-06-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022032-00190233912025-08-16Drug product2015-06-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022032-00190233912025-08-16Drug product2015-06-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022032-00190233912025-08-16Drug product2015-06-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022032-00190233912025-08-16Drug product2015-06-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022032-00190233912025-08-16Drug product2015-06-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022032-00190233912025-08-16Drug product2015-06-033f0d92c62455…
2023-05-13 08:27 UTC2023-05N022032-00190233912025-08-16Drug product2015-06-03053a50430f4f…
2023-01-26 05:58 UTC2023-01N022032-00190233912025-08-16Drug product2015-06-033bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022032-00190233912025-08-16Drug product2015-06-033a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022032-00190233912025-08-16Drug product2015-06-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022032-00190233912025-08-16Drug product2015-06-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022032-00190233912025-08-16Drug product2015-06-03cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022032-001125995652030-01-31Drug product2026-05-11a50c72e98297…

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 3 · 58 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Berkley and Jensen OmeprazoleOMEPRAZOLEBJWCf74752a8-a686-4c7d-91ad-8c87c4596a7a2026-05-21WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
care one omeprazoleOMEPRAZOLEAmerican Sales Companydb2d75ea-5924-4b7f-a92d-d4847a010d522026-04-17WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
omeprazoleOMEPRAZOLERite Aid Corporationee853401-b641-4dab-b708-29424c2d0b792026-03-25WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
omeprazoleOMEPRAZOLEHyVee Inca5df7dac-00f4-4d97-9586-cde3055890ac2026-02-04WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
omeprazoleOMEPRAZOLEHyVee Inccf9919e6-a839-4bad-a007-80d5bf6f81db2026-01-30WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
ndc (product): 42507-414
good neighbor pharmacy omeprazoleOMEPRAZOLEAmerisource Bergenf9aab207-d309-49b5-b941-c2912b1865832025-12-21WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
omeprazoleOMEPRAZOLEKroger Company015b1c8f-9d5b-4afc-a55c-1a731b5fc72a2025-12-08WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
dg health omeprazoleOMEPRAZOLEDolgencorp, LLC326bf21c-fad4-473e-9e7f-797319d4353a2025-09-02WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
omeprazoleOMEPRAZOLEKroger Companyda18d91c-5fe9-44d4-9d6f-602900af3f082025-06-04WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
careone omeprazoleOMEPRAZOLERetail Business Services, LLC063cfad8-3ca6-4b72-a4c9-512b8047bae32025-04-17WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
leader omeprazoleOMEPRAZOLECardinal Health 110, LLC. dba Leader19beab17-ca25-4be3-bada-20a2e9aa26b52025-04-16WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
rugby omeprazoleOMEPRAZOLERugby Laboratories61952807-f38d-4e7a-8646-a8ec85d7fb372025-04-15WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
careone omeprazoleOMEPRAZOLEAmerican Sales Companya5ec923a-dbc7-43e0-b3b8-f61dcaa6765d2025-04-14WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
signature care omeprazoleOMEPRAZOLESafeway85ece978-3cfb-4c09-bf0f-3217fda8e7d42025-04-14WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
equate omeprazoleOMEPRAZOLEWALMART INC.dcfe8e94-9c88-464e-9a80-3baa9c4755d92025-03-27WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
equate omeprazoleOMEPRAZOLEWal-Mart Stores Inc504b8282-d93f-454f-9f93-84cb8a9105d72025-03-25WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
omeprazoleOMEPRAZOLEH E B501d80c0-68ee-4fd9-bc56-0b214dbf72b52025-02-27WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
omeprazoleOMEPRAZOLEPadagis Israel Pharmaceuticals Ltdcb47354c-297b-4dc2-85af-242acc967b562025-02-06WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
Signature Care OmeprazoleOMEPRAZOLESafeway6361a492-782f-4608-a20f-1bd86afbd8642025-02-06WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
omeprazoleOMEPRAZOLEH E B5ceaec04-3ca3-4c7c-9184-51a42686a5952025-02-05WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032

Additional Listing Data#

Finished product
Yes
Brand name base
omeprazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KG60484QX9Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
402014Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cf9919e6-a839-4bad-a007-80d5bf6f81dbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42507-414-00omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE142
42507-414-01omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE12
42507-414-42omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE32

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNcf9919e6-a839-4bad-a007-80d5bf6f81db2
402014omeprazole 20 MG Delayed Release Oral TabletSCDcf9919e6-a839-4bad-a007-80d5bf6f81db2
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYcf9919e6-a839-4bad-a007-80d5bf6f81db2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42507-414-004250704140014 in 1 BOTTLEHistorical
42507-414-01425070414011 BOTTLE in 1 CARTON (42507-414-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (42507-414-00) 1 bottle2026-01-28NoNoCurrent
42507-414-42425070414423 BOTTLE in 1 CARTON (42507-414-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (42507-414-00) 3 bottle2026-01-28NoNoCurrent