FDA.reportPublic FDA data

Application 021229

Type
NDA
Sponsor
ASTRAZENECA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PRILOSEC OTCOMEPRAZOLE MAGNESIUMTABLET, DELAYED RELEASE;ORALEQ 20MG BASEYesYes

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
N021229-001PRILOSEC OTCOMEPRAZOLE MAGNESIUMEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD2003-06-20

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 UTC2022-10N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021229-001PRILOSEC OTCEQ 20MG BASETABLET, DELAYED RELEASE / ORALRLD, RS2003-06-20a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021229-00164288102019-11-0374a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021229-00164036162019-11-1574a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021229-00164288102019-11-033f01610625f2…
2019-12-14 00:12 UTC2019-12N021229-00164036162019-11-153f01610625f2…
2019-09-15 20:21 UTC2019-09N021229-00164288102019-11-03b00525d2431f…
2019-09-15 20:21 UTC2019-09N021229-00164036162019-11-15b00525d2431f…
2019-07-19 19:46 UTC2019-07N021229-00164288102019-11-03ea99ee380514…
2019-07-19 19:46 UTC2019-07N021229-00164036162019-11-15ea99ee380514…

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLE MAGNESIUMYYBA CORP535c2543-84f3-f5c1-e063-6394a90adb1e2026-07-07WarningsName fallback
generic name: OMEPRAZOLE MAGNESIUM
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMGericare Pharmaceuticals0e1f5d7c-5956-3be7-e054-00144ff8d46c2025-07-28WarningsName fallback
generic name: OMEPRAZOLE MAGNESIUM
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMHEB5d8b3f5f-f680-64ae-b360-c0bd06b2ac922025-07-23WarningsName fallback
generic name: OMEPRAZOLE MAGNESIUM
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMCVS Health Corp.3bbfa87d-f8b7-19bd-9f12-39cba31ae0b32025-07-23WarningsName fallback
generic name: OMEPRAZOLE MAGNESIUM
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMChain Drug Marketing Associationab5d339b-2c02-611d-d5db-8e1891684fe02025-07-23WarningsName fallback
generic name: OMEPRAZOLE MAGNESIUM
Acid ReducerOMEPRAZOLE MAGNESIUMLEADER/ Cardinal Health 110, Inc.1dc00f13-d1f5-15a0-32cc-4fc041865e722025-07-23WarningsName fallback
generic name: OMEPRAZOLE MAGNESIUM
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMAlbertsons Companies302b1332-181b-834b-4154-d849cb3a1ef02025-07-23WarningsName fallback
generic name: OMEPRAZOLE MAGNESIUM
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMDiscount Drug Mart, Incdaeeba93-29d5-efb4-a591-3e72c4e503412025-07-23WarningsName fallback
generic name: OMEPRAZOLE MAGNESIUM
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Inc.fe0eb905-2042-aed1-a67d-a219e76f679b2025-07-22WarningsName fallback
generic name: OMEPRAZOLE MAGNESIUM
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMWalgreens Companyee8b1740-9bcf-5b70-bd8d-97f98303dc722025-07-22WarningsName fallback
generic name: OMEPRAZOLE MAGNESIUM
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMChain Drug Consortium, LLC39ac65c0-d957-125f-f00b-e3846a4374892025-07-22WarningsName fallback
generic name: OMEPRAZOLE MAGNESIUM
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMChain Drug Marketing Associationfdf1259b-e9d3-70a9-c209-e2eb6b1528412025-07-22WarningsName fallback
generic name: OMEPRAZOLE MAGNESIUM
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Limited0e8fde83-a55c-edaf-3c66-e1fc77d0bc112025-05-28WarningsName fallback
generic name: OMEPRAZOLE MAGNESIUM
omeprazoleOMEPRAZOLE MAGNESIUMCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED8edfcc08-a14e-4579-bd44-045267de5b792025-04-02WarningsName fallback
generic name: OMEPRAZOLE MAGNESIUM
equate omeprazoleOMEPRAZOLE MAGNESIUMWALMART INC.6790b6c8-c258-4dfb-a400-25dc2812971f2025-03-26WarningsName fallback
generic name: OMEPRAZOLE MAGNESIUM
basic care omeprazoleOMEPRAZOLE MAGNESIUMAmazon.com Services LLCa4627be3-9845-428d-b3b1-c3096ae3d9b42024-09-05WarningsName fallback
generic name: OMEPRAZOLE MAGNESIUM
omeprazoleOMEPRAZOLE MAGNESIUMSafeway7ae4d70f-08f1-4586-965f-5a32fbe215912024-06-04WarningsName fallback
generic name: OMEPRAZOLE MAGNESIUM
omeprazoleOMEPRAZOLE MAGNESIUMMeijer, Inc.0340ef94-d2b4-47af-a045-d0d0312939842024-03-29WarningsName fallback
generic name: OMEPRAZOLE MAGNESIUM
PrilosecOMEPRAZOLE MAGNESIUMCovis Pharma US, Incb6761f84-53ac-4745-a8c8-1e5427d7e1792024-03-19Warnings, Adverse reactionsName fallback
generic name: OMEPRAZOLE MAGNESIUM
OmeprazoleOMEPRAZOLE MAGNESIUMWalgreen Company537b9a46-ecc8-4537-9657-c9ff7821dd4b2021-12-03WarningsName fallback
generic name: OMEPRAZOLE MAGNESIUM

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 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
37000-455Prilosec OTComeprazole magnesiumThe Procter & Gamble Manufacturing CompanyNDACurrent
37000-455Prilosec OTComeprazole magnesiumThe Procter & Gamble Manufacturing CompanyNDACurrent
37000-455Prilosec OTComeprazole magnesiumThe Procter & Gamble Manufacturing CompanyNDACurrent
37000-455Prilosec OTComeprazole magnesiumThe Procter & Gamble Manufacturing CompanyNDACurrent
37000-459Prilosec OTCOMEPRAZOLE MAGNESIUMThe Procter & Gamble Manufacturing CompanyNDACurrent
37000-459Prilosec OTCOMEPRAZOLE MAGNESIUMThe Procter & Gamble Manufacturing CompanyNDACurrent
37000-459Prilosec OTCOMEPRAZOLE MAGNESIUMThe Procter & Gamble Manufacturing CompanyNDACurrent
37000-459Prilosec OTCOMEPRAZOLE MAGNESIUMThe Procter & Gamble Manufacturing CompanyNDACurrent
70518-2167Prilosec OTComeprazole magnesiumREMEDYREPACK INC.NDACurrent
70518-2167Prilosec OTComeprazole magnesiumREMEDYREPACK INC.NDACurrent
70518-2167Prilosec OTComeprazole magnesiumREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72343SUPPL2022-10-14
72247SUPPL2022-10-05
61887SUPPL2020-02-14
61747SUPPL2020-01-31
58241SUPPL2019-04-08
58240SUPPL2019-04-08
54617SUPPL2018-06-20
54599SUPPL2018-06-14
53626SUPPL2018-04-05
53619SUPPL2018-04-05
45691SUPPL2016-10-27
45545SUPPL2016-10-14
36421SUPPL2015-07-02
27151SUPPL2015-06-24
14687SUPPL2013-09-19
27150SUPPL2013-09-10
4713SUPPL2012-09-14
14686SUPPL2012-03-27
4712SUPPL2011-08-31
4711SUPPL2011-07-25
27149SUPPL2011-06-29
27148SUPPL2011-03-02
27147SUPPL2010-12-22
27146SUPPL2010-07-08
27145SUPPL2009-11-10
27144SUPPL2008-06-20
4710SUPPL2008-03-04
4709SUPPL2008-01-24
27143SUPPL2007-03-23
14685SUPPL2007-03-23
27142SUPPL2006-10-05
14684SUPPL2006-10-05
42043ORIG2005-04-08
36420SUPPL2004-12-30
4708SUPPL2004-12-30
27141ORIG2003-06-24
23636ORIG2003-06-20
14683ORIG2003-06-20