FDA.reportPublic FDA data

Omeprazole

Product NDC
59651-001
11-digit product format
596510001
Labeler code
59651
Product ID
59651-001_4cc78adf-d6a3-47b6-bc25-9d3f28d2a27a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA203270
Marketing category
ANDA
Marketing start
2015-08-19
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, 200329

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
59651-001-01Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10019
59651-001-03Omeprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE319
59651-001-10Omeprazole10 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1019
59651-001-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3019
59651-001-78Omeprazole10 in 1 CARTONCAPSULE, DELAYED RELEASE1019
59651-001-99Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-001-01EA - Each59651-001f6220804-a183-45cb-91d4-db4b8548bb1f12018-07-03
59651-001-30EA - Each59651-00178637617-2d76-48aa-be8b-218975eda14912019-03-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671POMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENT94255I6E2TOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-001OMEPRAZOLE CAPSULE, DELAYED RELEASE [AUROBINDO PHARMA LIMITED]19Current NDC, Legacy NDC, 6 package rows20240618_934601b6-fbba-43c4-a8ef-7a7dfe9f9a51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199119omeprazole 10 MG Delayed Release Oral CapsulePSN934601b6-fbba-43c4-a8ef-7a7dfe9f9a5119
198051omeprazole 20 MG Delayed Release Oral CapsulePSN934601b6-fbba-43c4-a8ef-7a7dfe9f9a5119
200329omeprazole 40 MG Delayed Release Oral CapsulePSN934601b6-fbba-43c4-a8ef-7a7dfe9f9a5119
199119omeprazole 10 MG Delayed Release Oral CapsuleSCD934601b6-fbba-43c4-a8ef-7a7dfe9f9a5119
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD934601b6-fbba-43c4-a8ef-7a7dfe9f9a5119
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD934601b6-fbba-43c4-a8ef-7a7dfe9f9a5119
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSY934601b6-fbba-43c4-a8ef-7a7dfe9f9a5119
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY934601b6-fbba-43c4-a8ef-7a7dfe9f9a5119
199119omeprazole 10 MG Delayed Release Oral CapsulePSN61eab342-61fd-471f-8f70-95f9cbca00971
199119omeprazole 10 MG Delayed Release Oral CapsuleSCD61eab342-61fd-471f-8f70-95f9cbca00971
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSY61eab342-61fd-471f-8f70-95f9cbca00971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-001-0159651000101100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-001-01) 2015-08-190000-00-00NoNoCurrent
59651-001-03596510001033 BLISTER PACK in 1 CARTON (59651-001-03) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-001-10) 3 blister pack2015-08-190000-00-00NoNoCurrent
59651-001-105965100011010 in 1 BLISTER PACKHistorical
59651-001-305965100013030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-001-30) 2015-08-190000-00-00NoNoCurrent
59651-001-785965100017810 BLISTER PACK in 1 CARTON (59651-001-78) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (59651-001-10) 10 blister pack2015-08-190000-00-00NoNoCurrent
59651-001-99596510001991000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59651-001-99) 2015-08-190000-00-00NoNoCurrent