FDA.reportPublic FDA data

LANSOPRAZOLE

Product NDC
50090-2225
11-digit product format
500902225
Labeler code
50090
Product ID
50090-2225_b22a5352-c1ac-4e2a-b9c0-1439febf6a34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LANSOPRAZOLE
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA201921
Marketing category
ANDA
Marketing start
2012-12-18
Marketing end
0000-00-00
Substance
LANSOPRAZOLE
Active strength
30 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Inhibition Gastric Acid Secretion [PE]
NDC exclude flag
No
Listing certified through
2022-12-31
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
50090-2225-02023-01-30C16284748780-1f386c649-e1b8-0266-e053-dadaa90a7c1aThese 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 Initial U.S. Approval: 1995
50090-2225-12023-01-30C16284748780-1f386c649-e1b8-0266-e053-dadaa90a7c1aThese 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 Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2225-0LANSOPRAZOLE30 in 1 BOTTLECAPSULE, DELAYED RELEASE3013
50090-2225-1LANSOPRAZOLE90 in 1 BOTTLECAPSULE, DELAYED RELEASE9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2225-0EA - Each50090-2225a7f6edac-57be-4625-b5d7-6da81ab8fc2612019-02-13
50090-2225-1EA - Each50090-22256ced959e-b39c-4f85-85e0-a517e06d06df12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2225LANSOPRAZOLE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]13Legacy NDC, 2 package rows20210227_c3d4190d-5583-4121-814e-8c7eff73e1dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311277lansoprazole 30 MG Delayed Release Oral CapsulePSNc3d4190d-5583-4121-814e-8c7eff73e1dc13
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCDc3d4190d-5583-4121-814e-8c7eff73e1dc13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2225-05009022250030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-2225-0) 2015-11-090000-00-00NoNoCurrent
50090-2225-15009022250190 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-2225-1) 2015-11-090000-00-00NoNoCurrent