FDA.reportPublic FDA data

Omeprazole

Product NDC
0781-2785
11-digit product format
007812785
Labeler code
0781
Product ID
0781-2785_24a57c2e-eda8-4c3f-9c81-a28a5b9a9229
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA075757
Marketing category
ANDA
Marketing start
2003-01-28
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
0781-2785-01Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10011
0781-2785-10Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100011
0781-2785-31Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-2785-01EA - Each0781-27852a3c463a-a849-4e25-a56a-71b08004572212015-09-10
0781-2785-10EA - Each0781-2785b4362913-7b0e-4805-8a98-0e5a7337e54412015-08-04
0781-2785-31EA - Each0781-2785ff9876cb-9982-4618-9b48-a40ad3b3bc9b12015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]1
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]1
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]1
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]1
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-2785OMEPRAZOLE CAPSULE, DELAYED RELEASE [SANDOZ INC]11Current NDC, Legacy NDC, 3 package rows20231020_e4562da8-9d94-4417-9f80-c1ffd4247259.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199119omeprazole 10 MG Delayed Release Oral CapsulePSNe4562da8-9d94-4417-9f80-c1ffd424725911
198051omeprazole 20 MG Delayed Release Oral CapsulePSNe4562da8-9d94-4417-9f80-c1ffd424725911
199119omeprazole 10 MG Delayed Release Oral CapsuleSCDe4562da8-9d94-4417-9f80-c1ffd424725911
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDe4562da8-9d94-4417-9f80-c1ffd424725911
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSYe4562da8-9d94-4417-9f80-c1ffd424725911
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYe4562da8-9d94-4417-9f80-c1ffd424725911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0781-2785-0100781278501100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2785-01) 2003-01-280000-00-00NoNoCurrent
0781-2785-10007812785101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2785-10) 2003-01-280000-00-00NoNoCurrent
0781-2785-310078127853130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0781-2785-31) 2003-01-280000-00-00NoNoCurrent