FDA.reportPublic FDA data

Lansoprazole

Product NDC
71335-1521
11-digit product format
713351521
Labeler code
71335
Product ID
71335-1521_f26deb38-4659-4049-862d-fb7602a4d731
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207156
Marketing category
ANDA
Marketing start
2017-09-28
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-1521-12024-01-30C16284748780-11030e365-417d-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, USP, for oral use Initial U.S. Approval: 1995
71335-1521-22024-01-30C16284748780-11030e365-417d-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, USP, for oral use Initial U.S. Approval: 1995
71335-1521-32024-01-30C16284748780-11030e365-417d-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, USP, for oral use Initial U.S. Approval: 1995
71335-1521-42024-01-30C16284748780-11030e365-417d-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, USP, for oral use Initial U.S. Approval: 1995
71335-1521-52024-01-30C16284748780-11030e365-417d-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, USP, for oral use Initial U.S. Approval: 1995
71335-1521-62024-01-30C16284748780-11030e365-417d-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, USP, for oral use Initial U.S. Approval: 1995
71335-1521-72024-01-30C16284748780-11030e365-417d-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, USP, for oral use Initial U.S. Approval: 1995
71335-1521-82024-01-30C16284748780-11030e365-417d-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, USP, for oral use Initial U.S. Approval: 1995
71335-1521-92024-01-30C16284748780-11030e365-417d-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, USP, for oral use Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1521-1Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS306
71335-1521-2Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS906
71335-1521-3Lansoprazole18 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS186
71335-1521-4Lansoprazole28 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS286
71335-1521-5Lansoprazole56 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS566
71335-1521-6Lansoprazole58 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS586
71335-1521-7Lansoprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS606
71335-1521-8Lansoprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS1806
71335-1521-9Lansoprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS1206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1521LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [BRYANT RANCH PREPACK]6Legacy NDC, 9 package rows20220520_055d8e95-9dbb-4ab0-abcf-bdd48f63ff32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN055d8e95-9dbb-4ab0-abcf-bdd48f63ff326
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD055d8e95-9dbb-4ab0-abcf-bdd48f63ff326

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1521-17133515210130 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1521-1) 2020-03-310000-00-00NoNoCurrent
71335-1521-27133515210290 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1521-2) 2020-03-160000-00-00NoNoCurrent
71335-1521-37133515210318 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1521-3) 2021-12-280000-00-00NoNoCurrent
71335-1521-47133515210428 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1521-4) 2021-12-280000-00-00NoNoCurrent
71335-1521-57133515210556 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1521-5) 2017-09-280000-00-00NoNoCurrent
71335-1521-67133515210658 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1521-6) 2017-09-280000-00-00NoNoCurrent
71335-1521-77133515210760 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1521-7) 2017-09-280000-00-00NoNoCurrent
71335-1521-871335152108180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1521-8) 2017-09-280000-00-00NoNoCurrent
71335-1521-971335152109120 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1521-9) 2017-09-280000-00-00NoNoCurrent