FDA.reportPublic FDA data

OMEPRAZOLE

Product NDC
61919-847
11-digit product format
619190847
Labeler code
61919
Product ID
61919-847_c1c31f1c-23b7-6193-e053-2995a90abc73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OMEPRAZOLE
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Direct Rx
Application
ANDA091672
Marketing category
ANDA
Marketing start
2020-08-12
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
40 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
61919-847-142025-01-30C16284748780-12cef2736-abae-d83d-e063-dadaa90ab31fOMEPRAZOLE DR
61919-847-302025-01-30C16284748780-12cef2736-abae-d83d-e063-dadaa90ab31fOMEPRAZOLE DR
61919-847-602025-01-30C16284748780-12cef2736-abae-d83d-e063-dadaa90ab31fOMEPRAZOLE DR
61919-847-902025-01-30C16284748780-12cef2736-abae-d83d-e063-dadaa90ab31fOMEPRAZOLE DR

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-847-14OMEPRAZOLE14 in 1 BOTTLECAPSULE, DELAYED RELEASE1414
61919-847-30OMEPRAZOLE30 in 1 BOTTLECAPSULE, DELAYED RELEASE3014
61919-847-60OMEPRAZOLE60 in 1 BOTTLECAPSULE, DELAYED RELEASE6014
61919-847-90OMEPRAZOLE90 in 1 BOTTLECAPSULE, DELAYED RELEASE9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-847-14EA - Each61919-8473ed12b64-42ef-4934-adb5-11de1fcf3deb12023-04-07
61919-847-30EA - Each61919-8471eced823-3932-495e-b801-0a65d4a56a9b12022-10-06
61919-847-60EA - Each61919-84751adafa4-bf61-4253-b14f-baf1dea2e94412020-09-14
61919-847-90EA - Each61919-847adcd1f53-a854-4148-bca1-10eb6601d49512022-10-06

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
61919-847OMEPRAZOLE DR CAPSULE, DELAYED RELEASE OMEPRAZOLE CAPSULE, DELAYED RELEASE [DIRECT RX]14Legacy NDC, 4 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
61919-847-146191908471414 in 1 BOTTLEHistorical
61919-847-306191908473030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-847-30) 2020-08-120000-00-00NoNoCurrent
61919-847-606191908476060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-847-60) 2020-08-120000-00-00NoNoCurrent
61919-847-906191908479090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (61919-847-90) 2020-08-120000-00-00NoNoCurrent