Lansoprazole

Product NDC
68196-030
11-digit product format
681960030
Labeler code
68196
Product ID
68196-030_b20bf1de-1e61-404b-beed-87b7367fc683
Type
HUMAN OTC DRUG
Nonproprietary name
lansoprazole delayed release
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Sam's West, Inc.
Application
ANDA203187
Marketing category
ANDA
Marketing start
2017-07-06
Marketing end
0000-00-00
Substance
LANSOPRAZOLE
Active strength
15 mg/1
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
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68196-030-032024-01-30C16284748780-11030e365-5b85-111a-e063-dadaa90a10e2Lansoprazole DR Capsules USP 15 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-030-01Lansoprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
68196-030-03Lansoprazole3 in 1 PACKAGECAPSULE, DELAYED RELEASE35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-030LANSOPRAZOLE (LANSOPRAZOLE DELAYED RELEASE) CAPSULE, DELAYED RELEASE [SAM'S WEST, INC.]5Legacy NDC, 2 package rows20191219_2732e2b8-2ba0-40f3-9ca1-d6552c18455f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN2732e2b8-2ba0-40f3-9ca1-d6552c18455f5
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD2732e2b8-2ba0-40f3-9ca1-d6552c18455f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68196-030-016819600300114 in 1 BOTTLEHistorical
68196-030-03681960030033 BOTTLE in 1 PACKAGE (68196-030-03) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68196-030-01) 3 bottle2017-07-060000-00-00NoNoCurrent