Omeprazole

Product NDC
49999-265
11-digit product format
499990265
Labeler code
49999
Product ID
49999-265_7be9407c-cd50-4b34-8277-c96a8db74e5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA075576
Marketing category
ANDA
Marketing start
2010-10-13
Marketing end
2027-01-31
Substance
OMEPRAZOLE
Active strength
20 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
OMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui198051

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
49999-265-00Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE100339005
49999-265-01Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE120339005
49999-265-14Omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE14339005
49999-265-15Omeprazole15 in 1 BOTTLECAPSULE, DELAYED RELEASE15339005
49999-265-28Omeprazole28 in 1 BOTTLECAPSULE, DELAYED RELEASE28339005
49999-265-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE30339005
49999-265-60Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE60339005
49999-265-90Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE90339005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49999-265-00EA - Each49999-2651c7309c6-fdf6-4a90-adc8-aef6254003c412012-07-24
49999-265-01EA - Each49999-2654cc9238b-2db9-4c0a-91c0-5f26ec91ae6412017-04-05
49999-265-14EA - Each49999-265ae25af7c-6763-4513-807f-f70c40fb42d112017-04-05
49999-265-15EA - Each49999-2654ec23ce8-91ff-4e40-a4e5-3569b0700a5912012-07-24
49999-265-28EA - Each49999-265cd97e11d-680b-4d19-a3ab-7f3ec2ed224312012-07-24
49999-265-30EA - Each49999-265852d3237-8be2-41d3-b0ff-f67f6a0f859012012-07-24
49999-265-60EA - Each49999-26560c8ea27-0866-42fc-a195-472f7404c7f912012-07-24
49999-265-90EA - Each49999-2656b56f3f3-6085-4aac-ace0-c6cdcaa30f0812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHOMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
MANNITOLINACTIVE INGREDIENT3OWL53L36AOMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYOMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
POLOXAMER 124INACTIVE INGREDIENT1S66E28KXAOMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
POVIDONEINACTIVE INGREDIENTFZ989GH94EOMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]3379

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49999-265OMEPRAZOLE CAPSULE, DELAYED RELEASE [QUALITY CARE PRODUCTS, LLC]339005Current NDC, Legacy NDC, 8 package rows20241220_581d1c3d-457a-41f2-8db0-5b6219cdcb09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN581d1c3d-457a-41f2-8db0-5b6219cdcb09339005
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD581d1c3d-457a-41f2-8db0-5b6219cdcb09339005
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY581d1c3d-457a-41f2-8db0-5b6219cdcb09339005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49999-265-0049999026500100 in 1 BOTTLEHistorical
49999-265-0149999026501120 in 1 BOTTLEHistorical
49999-265-144999902651414 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49999-265-14) 2013-11-010000-00-00NoNoCurrent
49999-265-154999902651515 in 1 BOTTLEHistorical
49999-265-284999902652828 in 1 BOTTLEHistorical
49999-265-304999902653030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49999-265-30) 2013-11-012027-01-31NoNoCurrent
49999-265-604999902656060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49999-265-60) 2013-11-012027-01-31NoNoCurrent
49999-265-904999902659090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (49999-265-90) 2013-11-012027-01-31NoNoCurrent