FDA.reportPublic FDA data

lansoprazole

Product NDC
50090-3195
11-digit product format
500903195
Labeler code
50090
Product ID
50090-3195_b7475b90-34a3-4b39-be3b-c64b5c7e0500
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lansoprazole
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202366
Marketing category
ANDA
Marketing start
2013-08-23
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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
d6b97638-59f4-48e2-8959-569628732c46Product name920210622
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3195-02023-01-30C16284748780-1f386c64a-1fb1-0266-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
50090-3195-12023-01-30C16284748780-1f386c64a-1fb1-0266-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
50090-3195-0lansoprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS308
50090-3195-1lansoprazole90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE PELLETS908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3195-0EA - Each50090-3195d4e95ee0-5fd1-49b7-8809-63c483f034d112019-05-02
50090-3195-1EA - Each50090-3195ba528447-2e39-4060-83dd-2d465c72f13b12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3195LANSOPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [A-S MEDICATION SOLUTIONS]8Legacy NDC, 2 package rows20190427_4da1919d-b42f-4b7f-9885-528a095ab7c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311277lansoprazole 30 MG Delayed Release Oral CapsulePSN4da1919d-b42f-4b7f-9885-528a095ab7c38
311277lansoprazole 30 MG Delayed Release Oral CapsuleSCD4da1919d-b42f-4b7f-9885-528a095ab7c38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3195-05009031950030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (50090-3195-0) 2018-02-080000-00-00NoNoCurrent
50090-3195-15009031950190 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (50090-3195-1) 2014-11-280000-00-00NoNoCurrent