Omeprazole

Product NDC
51079-007
11-digit product format
510790007
Labeler code
51079
Product ID
51079-007_7e02f6ee-8d89-6aa2-e053-2991aa0a8d97
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA075876
Marketing category
ANDA
Marketing start
2003-09-01
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51079-007DDiscontinued by firm2026-08-03
excluded packagepackage51079-00751079-007-20DDiscontinued by firm2026-08-03

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 · 24 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 packagepackage51079-007-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51079-007-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51079-007-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51079-007-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51079-007-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51079-007-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51079-007-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51079-007-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51079-007-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51079-007-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51079-007-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51079-007-20557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075876-001OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29
A075876-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29
A075876-003OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-21

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-298072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A075876-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A075876-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075876-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A075876-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075876-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A075876-003AB1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-007-01EA - Each51079-007118b9ea4-8114-4347-b776-7f7d0be2b8fe12012-07-24
51079-007-17EA - Each51079-007dc161de4-7bba-4625-8f58-55038053f68412012-07-24
51079-007-19EA - Each51079-0071e6704a5-63c8-41ef-80b9-34466b431da812012-07-24
51079-007-20EA - Each51079-007dfd3b660-cef3-45b3-917a-084edffe3a7512012-07-24
51079-007-30EA - Each51079-00791c859e4-8760-4f51-b6e8-2a8e0258591312012-07-24
51079-007-56EA - Each51079-00783d7b36a-4410-45cd-a5d1-6d07d08d92f812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]6
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]6
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]6
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]6
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]6
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]6
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]6
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYOMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]6
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BOMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]6
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]6
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]6
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SOMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]6
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]6
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]6
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656OMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]6
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]6
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]6
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPOMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]6
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]6
SUCROSEINACTIVE INGREDIENTC151H8M554OMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]6
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]6
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH]6
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [MYLAN INSTITUTIONAL INC.]6