healthy accents omeprazole

Product NDC
55316-915
11-digit product format
553160915
Labeler code
55316
Product ID
55316-915_1e038768-5097-4c0b-82eb-f6145ac76c02
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
DZA Brands LLC
Application
NDA022032
Marketing category
NDA
Marketing start
2008-03-03
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
20 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55316-915DDiscontinued by firm2026-10-15
excluded packagepackage55316-91555316-915-01DDiscontinued by firm2026-10-15
excluded packagepackage55316-91555316-915-03DDiscontinued by firm2026-10-15
excluded packagepackage55316-91555316-915-30DDiscontinued by firm2026-10-15
excluded packagepackage55316-91555316-915-55DDiscontinued by firm2026-10-15
excluded packagepackage55316-91555316-915-74DDiscontinued by firm2026-10-15

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 2 · 72 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55316-915-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55316-915-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55316-915-03d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55316-915-55d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55316-915-74d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55316-915-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55316-915-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55316-915-03f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55316-915-55f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55316-915-74f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55316-915-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55316-915-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55316-915-032ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55316-915-552ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55316-915-742ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55316-915-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55316-915-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55316-915-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55316-915-55a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55316-915-74a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55316-915-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55316-915-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55316-915-03cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55316-915-55cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55316-915-74cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55316-915-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55316-915-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55316-915-03cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55316-915-55cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55316-915-74cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55316-915-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55316-915-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55316-915-03302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55316-915-55302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55316-915-74302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55316-915-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55316-915-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55316-915-03ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55316-915-55ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55316-915-74ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55316-915-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55316-915-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55316-915-030efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55316-915-550efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55316-915-740efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55316-915-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55316-915-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55316-915-03ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55316-915-55ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55316-915-74ad56d346431e…cc804d4bbf1e…

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 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04c2088c7a36db…
2026-09-14 22:38:342026-08N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-0484e616aacf4f…
2026-08-18 06:07:402026-07N022032-001OMEPRAZOLE20MGTABLET, DELAYED RELEASE / ORALRLD, RS2007-12-04caaa826d4ba7…
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…

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…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9HEALTHY ACCENTS OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DZA BRANDS LLC]4
OMEPRAZOLEACTIVE MOIETYKG60484QX9HEALTHY ACCENTS OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DZA BRANDS LLC]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZHEALTHY ACCENTS OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DZA BRANDS LLC]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675HEALTHY ACCENTS OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DZA BRANDS LLC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTHEALTHY ACCENTS OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DZA BRANDS LLC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOHEALTHY ACCENTS OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DZA BRANDS LLC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHEALTHY ACCENTS OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DZA BRANDS LLC]4
MONOETHANOLAMINEINACTIVE INGREDIENT5KV86114PTHEALTHY ACCENTS OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DZA BRANDS LLC]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HEALTHY ACCENTS OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DZA BRANDS LLC]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JHEALTHY ACCENTS OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DZA BRANDS LLC]4
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TGHEALTHY ACCENTS OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DZA BRANDS LLC]4
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIHEALTHY ACCENTS OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DZA BRANDS LLC]4
TALCINACTIVE INGREDIENT7SEV7J4R1UHEALTHY ACCENTS OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DZA BRANDS LLC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHEALTHY ACCENTS OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DZA BRANDS LLC]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMHEALTHY ACCENTS OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [DZA BRANDS LLC]4

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 2 of 3 · 57 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
omeprazoleOMEPRAZOLEH E B5ceaec04-3ca3-4c7c-9184-51a42686a5952025-02-05WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
kirkland signature omeprazoleOMEPRAZOLECostco Wholesale Company48a44d0c-3502-430b-8b75-188a49d14da22025-02-05WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
omeprazoleOMEPRAZOLEMeijer Distribution Inc925399c7-dcbc-4546-9111-2a98a11ba5382025-02-05WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
OmeprazoleOMEPRAZOLECVS Pharmacy64a62f09-19a9-4281-a55d-451fd33711c12025-01-17WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
dg health omeprazoleOMEPRAZOLEDolgencorp Inc6d19783d-2856-4a86-9f5c-6cc26b4ca33e2025-01-17WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
omeprazoleOMEPRAZOLEMeijer Distribution Inc4e849a58-ad34-4d6e-a065-d1e5a1ac82182025-01-16WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
omeprazoleOMEPRAZOLEH E B491e3710-9a15-4b07-ae22-923bd1152ecc2025-01-16WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
dg health omeprazoleOMEPRAZOLEDolgencorp Inc3c34fa4b-be9f-4aa6-ab6b-775b528a89492025-01-16WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
24 hr omeprazoleOMEPRAZOLEMeijer, Inc.36adb053-3189-4c91-87dd-e122a2c8e8122025-01-14WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
omeprazoleOMEPRAZOLECVS Pharmacyfb3b1c3b-d486-4fa6-9ebf-ee1812ed25122025-01-06WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
TopCare OmeprazoleOMEPRAZOLETopco Associates LLC4d98665d-38db-4c08-8406-cc0e45f7ab7c2025-01-02WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
up and up omeprazoleOMEPRAZOLETarget Corporationd664c45d-564a-4692-ae8f-8dd980ffcd872024-12-30WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
omeprazoleOMEPRAZOLEWalgreen Company30a893d2-198a-4184-81b4-02399324ff292024-12-20WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
Good Sense OmeprazoleOMEPRAZOLEL. Perrigo Company11dfbf6c-59bf-4a30-b627-f49ccd31c0d02024-12-19WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
basic care omeprazoleOMEPRAZOLEAmazon.com Services LLC548629d3-8d93-465d-b6ac-2a42bc0baebf2024-12-19WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
exchange select omeprazoleOMEPRAZOLEArmy & Air Force Exchange Service22b4492d-7afe-410f-97bf-57e4a57b1c272024-12-19WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
Equate omeprazole delayed release acid reducerOMEPRAZOLEWal-Mart Stores Inc9a0f2d8a-eaad-403b-90c3-0fd275abe4dc2024-12-08WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
foster and thrive omeprazoleOMEPRAZOLEStrategic Sourcing Services LLC51bcc19d-acfc-487b-870b-251c8953741f2024-11-20WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
OmeprazoleOMEPRAZOLECVS Pharmacy19b5b960-cc4d-42d0-8c8a-04a355a4db922024-09-13WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032
omeprazoleOMEPRAZOLEPublix Super Markets Ince4a68b0a-a550-4416-8911-1defe014ad892024-09-09WarningsExact identifier
application applno (NDA): 022032
application number: NDA022032