Omeprazole

Product NDC
70934-336
Requested package NDC
70934-336-30
11-digit product format
709340336
Labeler code
70934
Product ID
70934-336_b7b15df4-de8d-2f40-e053-2995a90a757d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Denton Pharma, Inc. dba Northwind Pharmaceuticals
Application
ANDA076515
Marketing category
ANDA
Marketing start
2019-04-18
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
40 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70934-33670934-336-30IInactivated by FDA2026-08-17

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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

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
A076515-001OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A076515-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALAB2009-01-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-213f01610625f2…
2019-09-15 20:21 UTC2019-09A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076515-001OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2009-01-21e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076515-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076515-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076515-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076515-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076515-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076515-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076515-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076515-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076515-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076515-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076515-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076515-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076515-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076515-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076515-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076515-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076515-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076515-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076515-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076515-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076515-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076515-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076515-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076515-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076515-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076515-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076515-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076515-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076515-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076515-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076515-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076515-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076515-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076515-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076515-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076515-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076515-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076515-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076515-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076515-001AB1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-336-30Omeprazole30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE302
70934-336-90Omeprazole90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-336-30EA - Each70934-336e066994d-e948-4ef0-a465-364cbc31c78e12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-336OMEPRAZOLE CAPSULE, DELAYED RELEASE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]2Legacy NDC, 2 package rows20201231_89691e50-c250-6c87-e053-2995a90a2705.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLESandoz Inc5a09ce48-7139-4fc7-9b6e-439459c8e8662024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076515
application number: ANDA076515

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSN89691e50-c250-6c87-e053-2995a90a27052
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD89691e50-c250-6c87-e053-2995a90a27052

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-336-307093403363030 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70934-336-30) 2020-07-230000-00-00NoNoCurrent