FDA.reportPublic FDA data

Omeprazole

Product NDC
70934-118
11-digit product format
709340118
Labeler code
70934
Product ID
70934-118_a8c58b51-2a87-1130-e053-2995a90a2a1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA075576
Marketing category
ANDA
Marketing start
2018-05-11
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
No
Listing certified through
2021-12-31
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
70934-118-302022-01-28C16284748780-1d6a99b39-c9e4-a426-e053-dadaa90af4c2These 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. OMEPRAZOLE delayed-release capsules, for oral use INITIAL U.S. APPROVAL: 1989
70934-118-602022-01-28C16284748780-1d6a99b39-c9e4-a426-e053-dadaa90af4c2These 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. OMEPRAZOLE delayed-release capsules, for oral use INITIAL U.S. APPROVAL: 1989
70934-118-902022-01-28C16284748780-1d6a99b39-c9e4-a426-e053-dadaa90af4c2These 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. OMEPRAZOLE delayed-release capsules, for oral use INITIAL U.S. APPROVAL: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-118-30Omeprazole30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE303
70934-118-60Omeprazole60 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE603
70934-118-90Omeprazole90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-118-30EA - Each70934-118abdbead1-3b64-4e86-b2b7-43dc2dc962df12023-01-09
70934-118-60EA - Each70934-1182134d0ed-5ae4-45b0-89ab-beec3a59955912018-11-06
70934-118-90EA - Each70934-118bb48e791-f870-4f37-b2c0-3299e366c2f612022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-118OMEPRAZOLE CAPSULE, DELAYED RELEASE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]3Legacy NDC, 3 package rows20200930_737ec163-f078-c3b3-e053-2a91aa0a245c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN737ec163-f078-c3b3-e053-2a91aa0a245c3
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD737ec163-f078-c3b3-e053-2a91aa0a245c3
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY737ec163-f078-c3b3-e053-2a91aa0a245c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-118-307093401183030 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70934-118-30) 2020-06-160000-00-00NoNoCurrent
70934-118-607093401186060 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70934-118-60) 2018-05-110000-00-00NoNoCurrent
70934-118-907093401189090 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70934-118-90) 2018-12-120000-00-00NoNoCurrent