FDA.reportPublic FDA data

Omeprazole

Product NDC
42254-053
11-digit product format
422540053
Labeler code
42254
Product ID
42254-053_fac73e19-3809-4846-8abc-f42a47c224ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA075576
Marketing category
ANDA
Marketing start
2007-10-22
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-053-072019-09-24C16284748780-19350213a-3cec-c013-e053-90daa90a1393Omeprazole Delayed-Release Capsules These highlights do not include all the information needed to use See full prescribing information for use INITIAL U.S. APPROVAL: 2007
42254-053-142019-09-24C16284748780-19350213a-3cec-c013-e053-90daa90a1393Omeprazole Delayed-Release Capsules These highlights do not include all the information needed to use See full prescribing information for use INITIAL U.S. APPROVAL: 2007
42254-053-302019-09-24C16284748780-19350213a-3cec-c013-e053-90daa90a1393Omeprazole Delayed-Release Capsules These highlights do not include all the information needed to use See full prescribing information for use INITIAL U.S. APPROVAL: 2007
42254-053-602019-09-24C16284748780-19350213a-3cec-c013-e053-90daa90a1393Omeprazole Delayed-Release Capsules These highlights do not include all the information needed to use See full prescribing information for use INITIAL U.S. APPROVAL: 2007
42254-053-722019-09-24C16284748780-19350213a-3cec-c013-e053-90daa90a1393Omeprazole Delayed-Release Capsules These highlights do not include all the information needed to use See full prescribing information for use INITIAL U.S. APPROVAL: 2007
42254-053-902019-09-24C16284748780-19350213a-3cec-c013-e053-90daa90a1393Omeprazole Delayed-Release Capsules These highlights do not include all the information needed to use See full prescribing information for use INITIAL U.S. APPROVAL: 2007

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-053-07Omeprazole7 in 1 BOTTLECAPSULE, DELAYED RELEASE72
42254-053-14Omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
42254-053-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE302
42254-053-60Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE602
42254-053-72Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1202
42254-053-90Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-053-07EA - Each42254-053c7b84926-0b58-436e-aff3-850f6f34755312012-07-24
42254-053-14EA - Each42254-0539c1fbcd3-ff08-41ac-a08f-36a6d34157fd12012-07-24
42254-053-30EA - Each42254-05368b73dce-7814-4b91-a07d-09c76ef184e212012-07-24
42254-053-60EA - Each42254-0530c99a1f4-66fc-4bc3-a705-196dc7753ed112012-07-24
42254-053-72EA - Each42254-053f1a78552-6905-4477-9cc9-7703874c3efb12012-07-24
42254-053-90EA - Each42254-053ed7aec23-024e-4e8a-b045-3f35f253ccea12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OmeprazoleACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
omeprazoleACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
crospovidoneINACTIVE INGREDIENT68401960MKOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
MEGLUMINEINACTIVE INGREDIENT6HG8UB2MUYOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
POLOXAMER 124INACTIVE INGREDIENT1S66E28KXAOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-053OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]2Legacy NDC, 6 package rows20120621_60752a58-1d6c-4b4d-98dd-d49c76d2f443.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199119omeprazole 10 MG Delayed Release Oral CapsulePSN60752a58-1d6c-4b4d-98dd-d49c76d2f4432
198051omeprazole 20 MG Delayed Release Oral CapsulePSN60752a58-1d6c-4b4d-98dd-d49c76d2f4432
199119omeprazole 10 MG Delayed Release Oral CapsuleSCD60752a58-1d6c-4b4d-98dd-d49c76d2f4432
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD60752a58-1d6c-4b4d-98dd-d49c76d2f4432
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSY60752a58-1d6c-4b4d-98dd-d49c76d2f4432
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY60752a58-1d6c-4b4d-98dd-d49c76d2f4432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-053-07422540053077 in 1 BOTTLEHistorical
42254-053-144225400531414 in 1 BOTTLEHistorical
42254-053-304225400533030 in 1 BOTTLEHistorical
42254-053-604225400536060 in 1 BOTTLEHistorical
42254-053-7242254005372120 in 1 BOTTLEHistorical
42254-053-904225400539090 in 1 BOTTLEHistorical