FDA.reportPublic FDA data

Omeprazole

Product NDC
0781-2859
11-digit product format
007812859
Labeler code
0781
Product ID
0781-2859_b182f298-e28f-434b-b6f1-ecfac29d495e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA075757
Marketing category
ANDA
Marketing start
2019-07-01
Substance
OMEPRAZOLE
Active strength
10 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 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
ndc (product): 0781-2859
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

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE10 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198051Internal RxNorm lookup
199119Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
516170d4-4913-4577-a2d2-f5c52d1e79c6Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-2859-01Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1009
0781-2859-10Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE10009
0781-2859-31Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE309
0781-2859-92Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-2859-01EA - Each0781-2859f056be4b-5189-406c-85d3-b77e7c9f4dd112019-08-06
0781-2859-10EA - Each0781-2859272bf60a-5ede-43b3-b5a0-00e510ee523b12019-08-06
0781-2859-31EA - Each0781-28593db4ce00-685d-4c87-b15d-37dfd274aba012019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-2859OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]8Current NDC, Legacy NDC, 4 package rows20231216_516170d4-4913-4577-a2d2-f5c52d1e79c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199119omeprazole 10 MG Delayed Release Oral CapsulePSN516170d4-4913-4577-a2d2-f5c52d1e79c69
198051omeprazole 20 MG Delayed Release Oral CapsulePSN516170d4-4913-4577-a2d2-f5c52d1e79c69
199119omeprazole 10 MG Delayed Release Oral CapsuleSCD516170d4-4913-4577-a2d2-f5c52d1e79c69
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD516170d4-4913-4577-a2d2-f5c52d1e79c69
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSY516170d4-4913-4577-a2d2-f5c52d1e79c69
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY516170d4-4913-4577-a2d2-f5c52d1e79c69
199119omeprazole 10 MG Delayed Release Oral CapsulePSNee0598a1-0e5e-40ff-ad88-b0adfc533ca01
199119omeprazole 10 MG Delayed Release Oral CapsuleSCDee0598a1-0e5e-40ff-ad88-b0adfc533ca01
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSYee0598a1-0e5e-40ff-ad88-b0adfc533ca01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-2859-0100781285901100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2859-01) 2019-08-010000-00-00NoNoCurrent
0781-2859-10007812859101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2859-10) 2019-08-010000-00-00NoNoCurrent
0781-2859-310078128593130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2859-31) 2019-08-010000-00-00NoNoCurrent
0781-2859-920078128599290 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2859-92) 2019-07-010000-00-00NoNoCurrent