FDA.reportPublic FDA data

Lansoprazole

Product NDC
45865-879
11-digit product format
458650879
Labeler code
45865
Product ID
45865-879_7dcbbe7b-4edb-440a-e053-2a91aa0a41c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA091269
Marketing category
ANDA
Marketing start
2010-10-15
Marketing end
0000-00-00
Substance
LANSOPRAZOLE
Active strength
15 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]
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
45865-879-302025-01-30C16284748780-12cef2736-66a3-d83d-e063-dadaa90ab31fThese 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 delayed-release capsules LANSOPRAZOLE delayed-release capsules USP, for oral use For oral administration Initial U.S. Approval: 1995
45865-879-602025-01-30C16284748780-12cef2736-66a3-d83d-e063-dadaa90ab31fThese 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 delayed-release capsules LANSOPRAZOLE delayed-release capsules USP, for oral use For oral administration Initial U.S. Approval: 1995
45865-879-902025-01-30C16284748780-12cef2736-66a3-d83d-e063-dadaa90ab31fThese 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 delayed-release capsules LANSOPRAZOLE delayed-release capsules USP, for oral use For oral administration Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-879-30Lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE302
45865-879-60Lansoprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE602
45865-879-90Lansoprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-879LANSOPRAZOLE CAPSULE, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]2Legacy NDC, 3 package rows20181225_7dcbbe7b-4eda-440a-e053-2a91aa0a41c1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
596843lansoprazole 15 MG Delayed Release Oral CapsulePSN7dcbbe7b-4eda-440a-e053-2a91aa0a41c12
596843lansoprazole 15 MG Delayed Release Oral CapsuleSCD7dcbbe7b-4eda-440a-e053-2a91aa0a41c12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-879-304586508793030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-879-30) 2018-06-010000-00-00NoNoCurrent
45865-879-604586508796060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-879-60) 2018-06-010000-00-00NoNoCurrent
45865-879-904586508799090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (45865-879-90) 2018-06-010000-00-00NoNoCurrent