FDA.reportPublic FDA data

OMEPRAZOLE DR

Product NDC
61919-176
11-digit product format
619190176
Labeler code
61919
Product ID
61919-176_c1c31f1c-23b7-6193-e053-2995a90abc73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OMEPRAZOLE DR
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Direct Rx
Application
ANDA076048
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
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
Listing certified through
2023-12-31
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
61919-176-142025-01-30C16284748780-12cef2736-abae-d83d-e063-dadaa90ab31fOMEPRAZOLE DR
61919-176-152025-01-30C16284748780-12cef2736-abae-d83d-e063-dadaa90ab31fOMEPRAZOLE DR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-176-14OMEPRAZOLE DR14 in 1 BOTTLECAPSULE, DELAYED RELEASE1414
61919-176-15OMEPRAZOLE DR15 in 1 BOTTLECAPSULE, DELAYED RELEASE1514

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-176-14EA - Each61919-176981b9559-85eb-4a38-82f5-296fe0cd7f9d12019-09-05
61919-176-15EA - Each61919-1760df062ba-70cb-42c7-bd5c-d7b4d04be1c112014-05-02
61919-176-30EA - Each61919-176af6fdda9-f6dc-4fd3-9a5c-aaf0db5d8eed12014-05-02
61919-176-60EA - Each61919-17650d5e781-865f-4af9-a9a2-4b11f040b22c12014-05-02
61919-176-72EA - Each61919-176dbc21d32-f1ec-4363-9e87-1bae410c0cdf12014-05-02
61919-176-90EA - Each61919-176a5745734-801f-44c6-9038-aaaf58f0679712014-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
MAGNESIUM HYDROXIDEINACTIVE INGREDIENTNBZ3QY004SOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-176OMEPRAZOLE DR CAPSULE, DELAYED RELEASE OMEPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]14Legacy NDC, 2 package rows20230602_c6bc8fb7-2862-464a-b7c9-e409034f072a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNc6bc8fb7-2862-464a-b7c9-e409034f072a14
200329omeprazole 40 MG Delayed Release Oral CapsulePSNc6bc8fb7-2862-464a-b7c9-e409034f072a14
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDc6bc8fb7-2862-464a-b7c9-e409034f072a14
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDc6bc8fb7-2862-464a-b7c9-e409034f072a14
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYc6bc8fb7-2862-464a-b7c9-e409034f072a14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-176-146191901761414 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-176-14) 2015-01-010000-00-00NoNoCurrent
61919-176-156191901761515 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-176-15) 2015-01-010000-00-00NoNoCurrent