Omeprazole

Product NDC
50436-0146
11-digit product format
504360146
Labeler code
50436
Product ID
50436-0146_c45d7a7f-d9cf-42d1-9919-ad90c3e3a017
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA076048
Marketing category
ANDA
Marketing start
2009-01-21
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
40 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0146-1Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE305
50436-0146-2Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0146OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]5Legacy NDC, 2 package rows20170702_b6e75ecc-4332-4bfc-8a77-4721178ebcca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSNb6e75ecc-4332-4bfc-8a77-4721178ebcca5
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDb6e75ecc-4332-4bfc-8a77-4721178ebcca5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0146-15043601460130 in 1 BOTTLEHistorical
50436-0146-25043601460260 in 1 BOTTLEHistorical