FDA.reportPublic FDA data

Omeprazole

Product NDC
0615-8079
11-digit product format
006158079
Labeler code
0615
Product ID
0615-8079_0c6e0de8-3ef8-4745-9ce4-d52f7c28bde3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA091672
Marketing category
ANDA
Marketing start
2014-10-31
Substance
OMEPRAZOLE
Active strength
40 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A091672-001OMEPRAZOLEOMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31
A091672-002OMEPRAZOLEOMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2014-10-31
A091672-003OMEPRAZOLEOMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2014-10-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A091672-001AB
A091672-002AB
A091672-003AB

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 22:54:322026-06A091672-001OMEPRAZOLE10MGCAPSULE, DELAYED REL PELLETS / ORALAB2014-10-31a50c72e98297…
2026-08-01 22:54:322026-06A091672-002OMEPRAZOLE20MGCAPSULE, DELAYED REL PELLETS / ORALABRS2014-10-31a50c72e98297…
2026-08-01 22:54:322026-06A091672-003OMEPRAZOLE40MGCAPSULE, DELAYED REL PELLETS / ORALABRS2014-10-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091672-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A091672-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A091672-003AB1a50c72e98297…

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 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.a19ce586-59b7-4c2e-9e8d-12e8f0f058e22026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEHAWAII REPACK, INC.9359e826-5263-44fc-8dd3-9d0852fe42d62026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEBryant Ranch Prepackdcaadc8c-32d1-476f-b821-973c012b7fa72026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEUnit Dose Solutions, Inc.557d4c2c-5541-3a51-e063-6394a90ad2782026-06-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEREMEDYREPACK INC.d9b3918c-a66e-4277-8b8f-b7ece93fa7db2026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEST. MARY'S MEDICAL PARK PHARMACY4f5c91e6-6377-ca94-e063-6294a90a2f992026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
Omeprazole DROMEPRAZOLEAdvanced Rx Pharmacy of Tennessee, LLCc8bf92c9-1bab-7985-e053-2995a90a02252026-03-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEGlenmark Pharmaceuticals Inc., USAc6c22be1-659d-4e71-b292-701e27da201b2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEPreferred Pharmaceuticals Inc.fa0395a7-4353-4d64-9de8-d15857a7031c2026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEA-S Medication Solutions17ccdbe0-19c1-498d-8e81-578be549b4e52025-12-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEPreferred Pharmaceuticals Inc.aa8fc2ea-3942-453b-bc19-1e4b14ba69262025-09-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLC3d6e07d1-38b1-f2ab-e063-6294a90a34ac2025-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEAphena Pharma Solutions - Tennessee, LLCbab55f83-ba03-49a0-842a-19c9976b7fe82025-08-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEA-S Medication Solutions5bda70ae-c3f6-450b-892f-6814795dd6ca2025-08-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEPHOENIX RX LLC3a9baece-03be-6c77-e063-6394a90a70322025-07-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEAsclemed USA, Inc.9c41bcfa-b08b-3ac3-e053-2a95a90ae1c02025-02-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLENCS HealthCare of KY, LLC dba Vangard Labsd1e0c8fc-1f15-45a4-a80f-653a1dae5e562025-01-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
ndc (product): 0615-8079
Omeprazole DROMEPRAZOLEAdvanced Rx of Tennessee, LLCaf85afda-6b0c-d657-e053-2a95a90afb4b2024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEA-S Medication Solutions30e58465-c5d2-4925-85bb-53faa6135c5c2024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672
OmeprazoleOMEPRAZOLEProficient Rx LP5ad413ed-a21b-4f8b-9322-8fbb813b14d32024-09-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091672
application number: ANDA091672

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KG60484QX9Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200329Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d1e0c8fc-1f15-45a4-a80f-653a1dae5e56Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8079-05Omeprazole15 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1516
0615-8079-07Omeprazole7 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE716
0615-8079-28Omeprazole28 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE2816
0615-8079-39Omeprazole30 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE3016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8079OMEPRAZOLE CAPSULE, DELAYED RELEASE [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]16Current NDC, Legacy NDC, 4 package rows20250119_d1e0c8fc-1f15-45a4-a80f-653a1dae5e56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSNd1e0c8fc-1f15-45a4-a80f-653a1dae5e5616
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDd1e0c8fc-1f15-45a4-a80f-653a1dae5e5616

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0615-8079-050061580790515 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-05) 2014-10-310000-00-00NoNoCurrent
0615-8079-07006158079077 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-07) 2018-11-020000-00-00NoNoCurrent
0615-8079-280061580792828 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-28) 2025-01-10NoNoCurrent
0615-8079-390061580793930 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8079-39) 2014-10-310000-00-00NoNoCurrent