FDA.reportPublic FDA data

Application 022032

Type
NDA
Sponsor
DEXCEL PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OMEPRAZOLEOMEPRAZOLETABLET, DELAYED RELEASE;ORAL20MGYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-10-15 13:18:302026-09N022032-001125995652030-01-31Drug product2026-05-11c2088c7a36db…
2026-09-14 22:38:342026-08N022032-001125995652030-01-31Drug product2026-05-1184e616aacf4f…
2026-08-18 06:07:402026-07N022032-001125995652030-01-31Drug product2026-05-11caaa826d4ba7…
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…

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 · 57 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEAmazon.com Services LLC94faa721-e925-4033-8661-d1990dfa920d2026-08-30WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
good now omeprazoleOMEPRAZOLEGobrands, Inc0e7c4aee-2c9f-4d5c-9d47-c333bf00ba9f2026-08-19WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
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
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
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
ndc (product): 30142-557
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
ndc (product): 21130-401
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
ndc (product): 21130-137

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 3 · 175 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0915Good Sense OmeprazoleOmeprazoleL. Perrigo CompanyNDACurrent
0113-0915Good Sense OmeprazoleOmeprazoleL. Perrigo CompanyNDACurrent
0113-1723Good Sense OmeprazoleOmeprazoleL. Perrigo CompanyNDACurrent
0113-1723Good Sense OmeprazoleOmeprazoleL. Perrigo CompanyNDACurrent
0113-1803good sense omeprazole delayed releaseomeprazoleL. Perrigo CompanyNDACurrent
0113-7401Basic Care OmeprazoleOmeprazoleL. Perrigo CompanyNDACurrent
0113-7401Basic Care OmeprazoleOmeprazoleL. Perrigo CompanyNDACurrent
0113-7401Basic Care OmeprazoleOmeprazoleL. Perrigo CompanyNDACurrent
0113-7915Basic Care OmeprazoleOmeprazoleL. Perrigo CompanyNDACurrent
0113-7915Basic Care OmeprazoleOmeprazoleL. Perrigo CompanyNDACurrent
0363-0007omeprazoleOmeprazoleWalgreen CompanyNDACurrent
0363-0007omeprazoleOmeprazoleWalgreen CompanyNDACurrent
0363-0007omeprazoleOmeprazoleWalgreen CompanyNDACurrent
0363-0007omeprazoleOmeprazoleWalgreen CompanyNDACurrent
0363-0007omeprazoleOmeprazoleWalgreen CompanyNDACurrent
0363-0915omeprazoleOmeprazoleWalgreen CompanyNDACurrent
0363-0915omeprazoleOmeprazoleWalgreen CompanyNDACurrent
0904-5834omeprazoleOmeprazoleMajor PharmaceuticalsNDACurrent
0904-5834omeprazoleOmeprazoleMajor PharmaceuticalsNDACurrent
10202-915seven select omeprazoleOmeprazole7-ElevenNDACurrent
10202-915seven select omeprazoleOmeprazole7-ElevenNDACurrent
11383-257OmeprazoleOmeprazoleWeeks & Leo Co., Inc.NDACurrent
11673-018up and up omeprazoleOmeprazoleTarget CorporationNDACurrent
11673-018up and up omeprazoleOmeprazoleTarget CorporationNDACurrent
11673-018up and up omeprazoleOmeprazoleTarget CorporationNDACurrent
11673-018up and up omeprazoleOmeprazoleTarget CorporationNDACurrent
11673-346up and up omeprazoleomeprazoleTarget CorporationNDACurrent
11673-915up and up omeprazoleOmeprazoleTarget CorporationNDACurrent
11673-915up and up omeprazoleOmeprazoleTarget CorporationNDACurrent
11673-915up and up omeprazoleOmeprazoleTarget CorporationNDACurrent
11673-915up and up omeprazoleOmeprazoleTarget CorporationNDACurrent
11673-915up and up omeprazoleOmeprazoleTarget CorporationNDACurrent
11822-0453omeprazoleOmeprazoleRite Aid CorporationNDACurrent
11822-0453omeprazoleOmeprazoleRite Aid CorporationNDACurrent
11822-0915omeprazoleOmeprazoleRite Aid CorporationNDACurrent
11822-0915omeprazoleOmeprazoleRite Aid CorporationNDACurrent
11822-0915omeprazoleOmeprazoleRite Aid CorporationNDACurrent
11822-1190omeprazoleomeprazoleRite Aid CorporationNDACurrent
21130-137Signature Care OmeprazoleOmeprazoleSafewayNDACurrent
21130-137Signature Care OmeprazoleOmeprazoleSafewayNDACurrent
21130-137Signature Care OmeprazoleOmeprazoleSafewayNDACurrent
21130-401signature care omeprazoleomeprazoleSafewayNDACurrent
21130-401signature care omeprazoleomeprazoleSafewayNDACurrent
30142-557omeprazoleOmeprazoleKroger CompanyNDACurrent
30142-557omeprazoleOmeprazoleKroger CompanyNDACurrent
30142-557omeprazoleOmeprazoleKroger CompanyNDACurrent
30142-557omeprazoleOmeprazoleKroger CompanyNDACurrent
30142-593OmeprazoleOmeprazoleKroger CompanyNDACurrent
30142-593OmeprazoleOmeprazoleKroger CompanyNDACurrent
30142-593OmeprazoleOmeprazoleKroger CompanyNDACurrent
30142-593OmeprazoleOmeprazoleKroger CompanyNDACurrent
30142-593OmeprazoleOmeprazoleKroger CompanyNDACurrent
30142-593OmeprazoleOmeprazoleKroger CompanyNDACurrent
36800-121TopCare Omeprazole delayed releaseOmeprazoleTopco Associates LLCNDACurrent
36800-121TopCare Omeprazole delayed releaseOmeprazoleTopco Associates LLCNDACurrent
36800-121TopCare Omeprazole delayed releaseOmeprazoleTopco Associates LLCNDACurrent
36800-915TopCare OmeprazoleOmeprazoleTopco Associates LLCNDACurrent
36800-915TopCare OmeprazoleOmeprazoleTopco Associates LLCNDACurrent
36800-915TopCare OmeprazoleOmeprazoleTopco Associates LLCNDACurrent
37012-401OmeprazoleOmeprazoleShopko Stores Operating Co., LLCNDACurrent
37012-401OmeprazoleOmeprazoleShopko Stores Operating Co., LLCNDACurrent
37012-915OmeprazoleOmeprazoleShopko Stores Operating Co., LLCNDACurrent
37205-837leader omeprazoleOmeprazoleCardinal HealthNDACurrent
37808-401omeprazoleOmeprazoleH E BNDACurrent
37808-401omeprazoleOmeprazoleH E BNDACurrent
37808-401omeprazoleOmeprazoleH E BNDACurrent
37808-915omeprazoleOmeprazoleH E BNDACurrent
37808-915omeprazoleOmeprazoleH E BNDACurrent
37808-915omeprazoleOmeprazoleH E BNDACurrent
37808-915omeprazoleOmeprazoleH E BNDACurrent
41163-614equaline omeprazole delayed releaseOmeprazoleSupervalu IncNDACurrent
41163-614equaline omeprazole delayed releaseOmeprazoleSupervalu IncNDACurrent
41163-915equaline omeprazoleOmeprazoleSupervalu IncNDACurrent
41163-915equaline omeprazoleOmeprazoleSupervalu IncNDACurrent
41190-915ShopRite OmeprazoleOmeprazoleWakefern Food CorporationNDACurrent
41250-401omeprazoleOmeprazoleMeijer Distribution IncNDACurrent
41250-401omeprazoleOmeprazoleMeijer Distribution IncNDACurrent
41250-401omeprazoleOmeprazoleMeijer Distribution IncNDACurrent
41250-401omeprazoleOmeprazoleMeijer Distribution IncNDACurrent
41250-401omeprazoleOmeprazoleMeijer Distribution IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
83675SUPPL 2025-10-07
83665SUPPL 2025-10-06
81678SUPPL 2025-03-24
80200SUPPL 2024-11-12
80199SUPPL 2024-11-12
72399SUPPL2022-10-17
72315SUPPL2022-10-13
72252SUPPL2022-10-05
72212SUPPL2022-10-03
68033SUPPL2021-07-08
58277SUPPL2019-04-10
58273SUPPL2019-04-10
50429SUPPL2017-11-15
50411SUPPL2017-11-14
50362SUPPL2017-11-13
50295SUPPL2017-11-06
38112SUPPL2016-02-11
6733SUPPL2016-02-11
16804SUPPL2015-06-19
6732SUPPL2015-06-12
38111SUPPL2015-03-12
29114SUPPL2015-03-10
16803SUPPL2014-01-15
38110SUPPL2013-09-19
29113SUPPL2013-08-20
6731SUPPL2012-10-30
6730SUPPL2012-09-11
29112SUPPL2012-04-11
6729SUPPL2011-07-05
29111SUPPL2010-07-23
16802SUPPL2009-07-24
6728SUPPL2009-07-23
44669ORIG2009-05-28
21912ORIG2009-05-28
29110SUPPL2009-04-07
29109ORIG2008-01-09
6727ORIG2007-07-05