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

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 Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui198051, 199119

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 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