FDA.reportPublic FDA data

Omeprazole

Product NDC
21695-097
11-digit product format
216950097
Labeler code
21695
Product ID
21695-097_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
2003-09-03
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
10 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
21695-097-302019-09-24C16284748780-1934fe258-4a31-48b1-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
21695-097-602019-09-24C16284748780-1934fe258-4a31-48b1-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
21695-097-722019-09-24C16284748780-1934fe258-4a31-48b1-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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-097-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE301
21695-097-60Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE601
21695-097-72Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-097-30EA - Each21695-0978ece4580-c75a-46d9-b89c-9b3ce00cb03512012-07-24
21695-097-60EA - Each21695-097f7fd4770-ef3c-4db0-be94-ace47937dda812012-07-24
21695-097-72EA - Each21695-0977fffdb26-5099-4cc1-ba85-c877406d2a9f12012-07-24

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
21695-097OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 3 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
21695-097-302169500973030 in 1 BOTTLEHistorical
21695-097-602169500976060 in 1 BOTTLEHistorical
21695-097-7221695009772120 in 1 BOTTLEHistorical