FDA.reportPublic FDA data

Omeprazole

Product NDC
67046-700
11-digit product format
670460700
Labeler code
67046
Product ID
67046-700_74f89ebc-df4b-cace-e053-2991aa0a65e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA075757
Marketing category
ANDA
Marketing start
2003-01-28
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
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67046-700IInactivated by FDA2026-08-03
excluded packagepackage67046-70067046-700-30IInactivated by FDA2026-08-03
excluded packagepackage67046-70067046-700-60IInactivated by FDA2026-08-03

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075757-001OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-28
A075757-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075757-001AB
A075757-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075757-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-28a50c72e98297…
2026-08-01 22:54:322026-06A075757-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALAB2003-01-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075757-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075757-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLESt. Mary's Medical Park Pharmacydb9f071b-85f4-061f-e053-2995a90a3ff52026-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
OmeprazoleOMEPRAZOLEQPharma Incf6f6ad19-ff6a-7cd3-e053-6294a90ae1bf2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
OmeprazoleOMEPRAZOLENorthwind Health Company, LLCf76c23d5-26b6-cfb2-e053-6294a90aea422026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
OmeprazoleOMEPRAZOLEPreferred Pharmaceuticals Inc.0fb314cb-6291-422c-98ff-24d8449992f62025-04-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
OmeprazoleOMEPRAZOLEChartwell RX, LLC4b1a6f05-ae3e-4f29-bc2d-8e9f51e5fe3e2025-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
OmeprazoleOMEPRAZOLESandoz Inc516170d4-4913-4577-a2d2-f5c52d1e79c62024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
OmeprazoleOMEPRAZOLEProficient Rx LPee0598a1-0e5e-40ff-ad88-b0adfc533ca02024-12-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
OmeprazoleOMEPRAZOLEBryant Ranch Prepack17664f71-154a-47c6-b83c-b349bbc8a98f2024-08-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757
OmeprazoleOMEPRAZOLESandoz Ince4562da8-9d94-4417-9f80-c1ffd42472592023-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075757
application number: ANDA075757

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-700-302022-01-28C16284748780-1d6a99b39-6a36-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989
67046-700-602022-01-28C16284748780-1d6a99b39-6a36-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use OMEPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for OMEPRAZOLE DELAYED-RELEASE CAPSULES. OMEPRAZOLE delayed-release capsules, for oral use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-700-30Omeprazole30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE301
67046-700-60Omeprazole60 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-700OMEPRAZOLE CAPSULE, DELAYED RELEASE [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 2 package rows20181230_74f888ce-5f95-cad0-e053-2991aa0a2d79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN74f888ce-5f95-cad0-e053-2991aa0a2d791
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD74f888ce-5f95-cad0-e053-2991aa0a2d791
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY74f888ce-5f95-cad0-e053-2991aa0a2d791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-700-306704607003030 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67046-700-30) 2018-05-310000-00-00NoNoCurrent
67046-700-606704607006060 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (67046-700-60) 2018-05-310000-00-00NoNoCurrent