Omeprazole

Product NDC
50436-3126
11-digit product format
504363126
Labeler code
50436
Product ID
50436-3126_7fce4798-80ad-48f3-adf1-a8d7f3e9e9a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA075576
Marketing category
ANDA
Marketing start
2009-01-21
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
40 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-3126-1Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE606
50436-3126-2Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-3126-1EA - Each50436-312656c024e2-c93b-4031-a990-52ff94c9c7bd12012-07-24
50436-3126-2EA - Each50436-3126f9cc4ca9-3a2f-4d80-9e8b-c53b53fa1c8012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3OMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHOMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8OMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AOMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYOMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
POLOXAMER 124INACTIVE INGREDIENT1S66E28KXAOMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EOMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE [UNIT DOSE SERVICES]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-3126OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]6Legacy NDC, 2 package rows20180720_c63b2dd4-ac8a-47a1-889b-94d68137bd01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSNc63b2dd4-ac8a-47a1-889b-94d68137bd016
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDc63b2dd4-ac8a-47a1-889b-94d68137bd016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-3126-15043631260160 in 1 BOTTLEHistorical
50436-3126-25043631260230 in 1 BOTTLEHistorical