FDA.reportPublic FDA data

Omeprazole

Product NDC
21695-098
11-digit product format
216950098
Labeler code
21695
Product ID
21695-098_b6939539-2d45-4ea0-9744-72d7691e331f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA075410
Marketing category
ANDA
Marketing start
2002-11-04
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
21695-098-072019-09-24C16284748780-1934fe258-4a31-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use Omeprazole Delayed-Release Capsules safely and effectively. See full prescribing information for Omeprazole Delayed-Release Capsules. Initial U.S. Approval: 2002
21695-098-102019-09-24C16284748780-1934fe258-4a31-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use Omeprazole Delayed-Release Capsules safely and effectively. See full prescribing information for Omeprazole Delayed-Release Capsules. Initial U.S. Approval: 2002
21695-098-142019-09-24C16284748780-1934fe258-4a31-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use Omeprazole Delayed-Release Capsules safely and effectively. See full prescribing information for Omeprazole Delayed-Release Capsules. Initial U.S. Approval: 2002
21695-098-152019-09-24C16284748780-1934fe258-4a31-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use Omeprazole Delayed-Release Capsules safely and effectively. See full prescribing information for Omeprazole Delayed-Release Capsules. Initial U.S. Approval: 2002
21695-098-302019-09-24C16284748780-1934fe258-4a31-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use Omeprazole Delayed-Release Capsules safely and effectively. See full prescribing information for Omeprazole Delayed-Release Capsules. Initial U.S. Approval: 2002
21695-098-602019-09-24C16284748780-1934fe258-4a31-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use Omeprazole Delayed-Release Capsules safely and effectively. See full prescribing information for Omeprazole Delayed-Release Capsules. Initial U.S. Approval: 2002
21695-098-722019-09-24C16284748780-1934fe258-4a31-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use Omeprazole Delayed-Release Capsules safely and effectively. See full prescribing information for Omeprazole Delayed-Release Capsules. Initial U.S. Approval: 2002
21695-098-902019-09-24C16284748780-1934fe258-4a31-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use Omeprazole Delayed-Release Capsules safely and effectively. See full prescribing information for Omeprazole Delayed-Release Capsules. Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-098-07Omeprazole07 in 1 BOTTLECAPSULE, DELAYED RELEASE071
21695-098-10Omeprazole10 in 1 BOTTLECAPSULE, DELAYED RELEASE101
21695-098-14Omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE141
21695-098-15Omeprazole15 in 1 BOTTLECAPSULE, DELAYED RELEASE151
21695-098-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
21695-098-60Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE601
21695-098-72Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1201
21695-098-90Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-098-07EA - Each21695-098b4443265-fda8-4609-9ecf-d5dd7b4c4dae12012-07-24
21695-098-10EA - Each21695-09898aff234-e2f4-49a0-828d-ba4bb2ea4e5612012-07-24
21695-098-14EA - Each21695-098cab110d6-a511-4903-979b-e043b5ef866412012-07-24
21695-098-15EA - Each21695-098825a8c41-5c45-4da8-9997-a5913a070a4c12012-07-24
21695-098-30EA - Each21695-09883a465e0-efec-4bca-90c3-33c79e42ea4e12012-07-24
21695-098-60EA - Each21695-0983e1c272d-6c11-49ee-973a-d08f110dddef12012-07-24
21695-098-72EA - Each21695-098ad972fe0-d718-4562-80d3-36e1b52a516612012-07-24
21695-098-90EA - Each21695-098f4d3a1d7-3be0-4535-91d1-856baff75d4512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
GLYCERYL BEHENATEINACTIVE INGREDIENTR8WTH25YS2OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-098OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 8 package rows20100202_d58c0b66-475f-46b3-949d-cda5343e7239.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199119omeprazole 10 MG Delayed Release Oral CapsulePSNd58c0b66-475f-46b3-949d-cda5343e72391
198051omeprazole 20 MG Delayed Release Oral CapsulePSNd58c0b66-475f-46b3-949d-cda5343e72391
199119omeprazole 10 MG Delayed Release Oral CapsuleSCDd58c0b66-475f-46b3-949d-cda5343e72391
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDd58c0b66-475f-46b3-949d-cda5343e72391
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSYd58c0b66-475f-46b3-949d-cda5343e72391
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYd58c0b66-475f-46b3-949d-cda5343e72391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-098-072169500980707 in 1 BOTTLEHistorical
21695-098-102169500981010 in 1 BOTTLEHistorical
21695-098-142169500981414 in 1 BOTTLEHistorical
21695-098-152169500981515 in 1 BOTTLEHistorical
21695-098-302169500983030 in 1 BOTTLEHistorical
21695-098-602169500986060 in 1 BOTTLEHistorical
21695-098-7221695009872120 in 1 BOTTLEHistorical
21695-098-902169500989090 in 1 BOTTLEHistorical