Omeprazole

Product NDC
68016-759
11-digit product format
680160759
Labeler code
68016
Product ID
68016-759_9a635296-1a26-3b0d-e053-2995a90a0969
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Chain Drug Consortium, LLC
Application
ANDA078878
Marketing category
ANDA
Marketing start
2013-04-01
Marketing end
0000-00-00
Substance
OMEPRAZOLE MAGNESIUM
Active strength
21 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68016-759DDiscontinued by firm2026-08-07
excluded packagepackage68016-75968016-759-14DDiscontinued by firm2026-08-07
excluded packagepackage68016-75968016-759-28DDiscontinued by firm2026-08-07
excluded packagepackage68016-75968016-759-42DDiscontinued by firm2026-08-07

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 · 48 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 packagepackage68016-759-42d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68016-759-28d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68016-759-14d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68016-759-42f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68016-759-28f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68016-759-14f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68016-759-422ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68016-759-282ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68016-759-142ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68016-759-42a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68016-759-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68016-759-14a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68016-759-42cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68016-759-28cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68016-759-14cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68016-759-42cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68016-759-28cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68016-759-14cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68016-759-42302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68016-759-28302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68016-759-14302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68016-759-42ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68016-759-28ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68016-759-14ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68016-759-420efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68016-759-280efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68016-759-140efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68016-759-42ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68016-759-28ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68016-759-14ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68016-759-42367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68016-759-28367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68016-759-14367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68016-759-42557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68016-759-28557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68016-759-14557ba5c1ecfa…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
A078878-001OMEPRAZOLE MAGNESIUMOMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05

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 UTC2026-02A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-053f01610625f2…
2019-09-15 20:21 UTC2019-09A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A078878-001OMEPRAZOLE MAGNESIUMEQ 20MG BASECAPSULE, DELAYED RELEASE / ORALRS2009-06-05cb3db0bc1861…

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 1 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMGericare Pharmaceuticals0e1f5d7c-5956-3be7-e054-00144ff8d46c2025-07-28WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMHEB5d8b3f5f-f680-64ae-b360-c0bd06b2ac922025-07-23WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMCVS Health Corp.3bbfa87d-f8b7-19bd-9f12-39cba31ae0b32025-07-23WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMChain Drug Marketing Associationab5d339b-2c02-611d-d5db-8e1891684fe02025-07-23WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Acid ReducerOMEPRAZOLE MAGNESIUMLEADER/ Cardinal Health 110, Inc.1dc00f13-d1f5-15a0-32cc-4fc041865e722025-07-23WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMAlbertsons Companies302b1332-181b-834b-4154-d849cb3a1ef02025-07-23WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMDiscount Drug Mart, Incdaeeba93-29d5-efb4-a591-3e72c4e503412025-07-23WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUM 20.6MG CAPSULESThe Kroger Co.8a6bbc31-7c50-a730-4233-e346fd7eb5ba2025-07-22WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Inc.fe0eb905-2042-aed1-a67d-a219e76f679b2025-07-22WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMWalgreens Companyee8b1740-9bcf-5b70-bd8d-97f98303dc722025-07-22WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUM 20.6MG CAPSULESWal-Mart Stores Inc3160e212-9ee9-8316-f51e-4628862f654c2025-07-22WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMChain Drug Consortium, LLC39ac65c0-d957-125f-f00b-e3846a4374892025-07-22WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMChain Drug Marketing Associationfdf1259b-e9d3-70a9-c209-e2eb6b1528412025-07-22WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878
Omeprazole MagnesiumOMEPRAZOLE MAGNESIUMDr. Reddy's Laboratories Limited0e8fde83-a55c-edaf-3c66-e1fc77d0bc112025-05-28WarningsExact identifier
application applno (ANDA): 078878
application number: ANDA078878

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-759-14680160759141 BOTTLE in 1 CARTON (68016-759-14) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2016-09-010000-00-00NoNoCurrent
68016-759-28680160759282 BOTTLE in 1 CARTON (68016-759-28) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2016-09-010000-00-00NoNoCurrent
68016-759-42680160759423 BOTTLE in 1 CARTON (68016-759-42) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2016-09-010000-00-00NoNoCurrent