FDA.reportPublic FDA data

Lansoprazole

Product NDC
71335-0917
11-digit product format
713350917
Labeler code
71335
Product ID
71335-0917_b0df2d75-3ed5-4627-9b1d-ad0fba80228f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091269
Marketing category
ANDA
Marketing start
2010-10-15
Marketing end
0000-00-00
Substance
LANSOPRAZOLE
Active strength
30 mg/1
Pharmacologic classes
Inhibition Gastric Acid Secretion [PE], 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
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0917-12024-01-30C16284748780-11030e365-6137-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use For oral administration Initial U.S. Approval: 1995
71335-0917-22024-01-30C16284748780-11030e365-6137-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use For oral administration Initial U.S. Approval: 1995
71335-0917-32024-01-30C16284748780-11030e365-6137-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use For oral administration Initial U.S. Approval: 1995
71335-0917-42024-01-30C16284748780-11030e365-6137-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use For oral administration Initial U.S. Approval: 1995
71335-0917-52024-01-30C16284748780-11030e365-6137-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use For oral administration Initial U.S. Approval: 1995
71335-0917-62024-01-30C16284748780-11030e365-6137-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use For oral administration Initial U.S. Approval: 1995
71335-0917-72024-01-30C16284748780-11030e365-6137-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use For oral administration Initial U.S. Approval: 1995
71335-0917-82024-01-30C16284748780-11030e365-6137-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use For oral administration Initial U.S. Approval: 1995
71335-0917-92024-01-30C16284748780-11030e365-6137-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use LANSOPRAZOLE DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for LANSOPRAZOLE DELAYED-RELEASE CAPSULES. LANSOPRAZOLE delayed-release capsules, for oral use For oral administration Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0917-1Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE30101
71335-0917-2Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE90101
71335-0917-3Lansoprazole18 in 1 BOTTLECAPSULE, DELAYED RELEASE18101
71335-0917-4Lansoprazole28 in 1 BOTTLECAPSULE, DELAYED RELEASE28101
71335-0917-5Lansoprazole56 in 1 BOTTLECAPSULE, DELAYED RELEASE56101
71335-0917-6Lansoprazole58 in 1 BOTTLECAPSULE, DELAYED RELEASE58101
71335-0917-7Lansoprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE60101
71335-0917-8Lansoprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE180101
71335-0917-9Lansoprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE120101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0917LANSOPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]101Legacy NDC, 9 package rows20220701_c3928dfc-c10b-456c-8826-f1a7956142ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNc3928dfc-c10b-456c-8826-f1a7956142ed101
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDc3928dfc-c10b-456c-8826-f1a7956142ed101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0917-17133509170130 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0917-1) 2018-07-310000-00-00NoNoCurrent
71335-0917-27133509170290 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0917-2) 2010-10-150000-00-00NoNoCurrent
71335-0917-37133509170318 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0917-3) 2010-10-150000-00-00NoNoCurrent
71335-0917-47133509170428 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0917-4) 2010-10-150000-00-00NoNoCurrent
71335-0917-57133509170556 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0917-5) 2022-02-090000-00-00NoNoCurrent
71335-0917-67133509170658 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0917-6) 2022-02-090000-00-00NoNoCurrent
71335-0917-77133509170760 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0917-7) 2022-02-090000-00-00NoNoCurrent
71335-0917-871335091708180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0917-8) 2022-02-090000-00-00NoNoCurrent
71335-0917-971335091709120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-0917-9) 2022-02-090000-00-00NoNoCurrent