FDA.reportPublic FDA data

Omeprazole

Product NDC
63187-061
11-digit product format
631870061
Labeler code
63187
Product ID
63187-061_0cc267bf-8650-40e3-a05d-e102e275c4c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076048
Marketing category
ANDA
Marketing start
2003-11-11
Marketing end
2027-01-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-061-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE307
63187-061-60Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE607
63187-061-72Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1207
63187-061-78Omeprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE1807
63187-061-90Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE907

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
OmeprazoleACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
MAGNESIUM HYDROXIDEINACTIVE INGREDIENTNBZ3QY004SOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-061OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]7Current NDC, Legacy NDC, 5 package rows20241025_03ac077f-3873-4087-96d0-89049161dea9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199119omeprazole 10 MG Delayed Release Oral CapsulePSN03ac077f-3873-4087-96d0-89049161dea97
198051omeprazole 20 MG Delayed Release Oral CapsulePSN03ac077f-3873-4087-96d0-89049161dea97
199119omeprazole 10 MG Delayed Release Oral CapsuleSCD03ac077f-3873-4087-96d0-89049161dea97
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD03ac077f-3873-4087-96d0-89049161dea97
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSY03ac077f-3873-4087-96d0-89049161dea97
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY03ac077f-3873-4087-96d0-89049161dea97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-061-306318700613030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-061-30) 2019-01-012027-01-31NoNoCurrent
63187-061-606318700616060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-061-60) 2019-01-012027-01-31NoNoCurrent
63187-061-7263187006172120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-061-72) 2019-01-012027-01-31NoNoCurrent
63187-061-7863187006178180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-061-78) 2019-01-012027-01-31NoNoCurrent
63187-061-906318700619090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (63187-061-90) 2019-01-012027-01-31NoNoCurrent