Good Sense Omeprazole

Product NDC
0113-0915
11-digit product format
001130915
Labeler code
0113
Product ID
0113-0915_1d135e1c-1e90-4e42-a2c7-2ef3b3fc6545
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
L. Perrigo Company
Application
NDA022032
Marketing category
NDA
Marketing start
2008-02-28
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
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0113-09150113-0915-01DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0113-09150113-0915-01DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0113-09150113-0915-01DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Good Sense Omeprazole
Listing expiration
2026-12-31

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
11dfbf6c-59bf-4a30-b627-f49ccd31c0d0Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-0915-01Good Sense Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE18
0113-0915-01Good Sense Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE148
0113-0915-03Good Sense Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE38
0113-0915-03Good Sense Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE148
0113-0915-30Good Sense Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE28
0113-0915-30Good Sense Omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE148
0113-0915-55Good Sense Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE38
0113-0915-55Good Sense Omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE148
0113-0915-74Good Sense Omeprazole1 in 1 BLISTER PACKTABLET, DELAYED RELEASE18
0113-0915-74Good Sense Omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE148

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0915-03EA - Each0113-091572580d7e-1510-41c1-b4b6-5ee09236ccba12023-01-09
0113-0915-30EA - Each0113-091509a1efbb-e64e-4eb2-9e47-59808d97656112012-07-24
0113-0915-55EA - Each0113-0915d08fc726-1e50-46e1-8710-2395227346c112012-07-24
0113-0915-74EA - Each0113-0915b41d3dfd-1637-4e84-a9fc-5f81a3cb8dd212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9GOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
OMEPRAZOLEACTIVE MOIETYKG60484QX9GOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZGOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
MONOETHANOLAMINEINACTIVE INGREDIENT5KV86114PTGOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TGGOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIGOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
TALCINACTIVE INGREDIENT7SEV7J4R1UGOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMGOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0915GOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]8Current NDC, Legacy NDC, 10 package rows20241225_11dfbf6c-59bf-4a30-b627-f49ccd31c0d0.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 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
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN11dfbf6c-59bf-4a30-b627-f49ccd31c0d08
402014omeprazole 20 MG Delayed Release Oral TabletSCD11dfbf6c-59bf-4a30-b627-f49ccd31c0d08
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY11dfbf6c-59bf-4a30-b627-f49ccd31c0d08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0915-01001130915011 BOTTLE in 1 CARTON (0113-0915-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2008-02-28NoNoCurrent
0113-0915-03001130915033 BOTTLE in 1 CARTON (0113-0915-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2017-06-080000-00-00NoNoCurrent
0113-0915-30001130915302 CARTON in 1 CARTON (0113-0915-30) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 carton2008-02-280000-00-00NoNoCurrent
0113-0915-55001130915553 CARTON in 1 CARTON (0113-0915-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK3 carton2008-02-280000-00-00NoNoCurrent
0113-0915-740011309157414 BLISTER PACK in 1 CARTON (0113-0915-74) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2008-02-280000-00-00NoNoCurrent