Omeprazole

Product NDC
66336-706
11-digit product format
663360706
Labeler code
66336
Product ID
66336-706_64218455-e1e2-4e40-bd32-5002d2d1555d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Dispensing Solutions, Inc.
Application
ANDA075876
Marketing category
ANDA
Marketing start
2012-12-12
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
E
Listing certified through
2017-12-31
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 productproduct66336-706IInactivated by FDA2026-09-09
excluded packagepackage66336-70666336-706-30IInactivated by FDA2026-09-09

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 · 44 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 packagepackage66336-706-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66336-706-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66336-706-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66336-706-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66336-706-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66336-706-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66336-706-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66336-706-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66336-706-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66336-706-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66336-706-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66336-706-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66336-706-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66336-706-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66336-706-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66336-706-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66336-706-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66336-706-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66336-706-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66336-706-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage66336-706-309bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage66336-706-30110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A075876-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29caaa826d4ba7…
2026-08-18 06:07:402026-07A075876-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORAL2003-05-29caaa826d4ba7…
2026-08-18 06:07:402026-07A075876-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORAL2009-01-21caaa826d4ba7…
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…

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66336-706-30Omeprazole30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66336-706-30EA - Each66336-7066ab00a2c-34e3-4781-8e1b-d69099bfdc6112013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66336-706OMEPRAZOLE CAPSULE, DELAYED RELEASE [DISPENSING SOLUTIONS, INC.]1Legacy NDC, 1 package rows20130704_8e3b29b0-d3a8-409a-b397-53dbbbcda094.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN8e3b29b0-d3a8-409a-b397-53dbbbcda0941
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD8e3b29b0-d3a8-409a-b397-53dbbbcda0941
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY8e3b29b0-d3a8-409a-b397-53dbbbcda0941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66336-706-306633607063030 in 1 BOTTLE, PLASTICHistorical