Olanzapine

Product NDC
53002-1505
11-digit product format
530021505
Labeler code
53002
Product ID
53002-1505_b3446bde-0f31-42b7-9b4c-c5073a8b8fc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA090798
Marketing category
ANDA
Marketing start
2012-04-23
Marketing end
0000-00-00
Substance
OLANZAPINE
Active strength
5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
42e9462d-db65-453b-8069-8fb2df9182e8Product name120211216
12d02c27-e8da-47f1-b815-ccca982731efProduct name920170802
877783eb-030c-6e3f-0979-804cf94d8856Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-1505-32025-01-30C16284748780-19d75b9d1-1458-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
53002-1505-32023-06-08C16284748780-19d75b9d1-1458-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
53002-1505-32023-01-30C16284748780-19d75b9d1-1458-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
53002-1505-32020-12-15C16284748780-19d75b9d1-1458-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996
53002-1505-32020-01-31C16284748780-19d75b9d1-1458-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use OLANZAPINE TABLETS safely and effectively. See full prescribing information for OLANZAPINE TABLETS. OLANZAPINE tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1505-3Olanzapine30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1505OLANZAPINE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 1 package rows20230609_c26391b1-fc43-4e9e-be05-0c47ab635939.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312078OLANZapine 5 MG Oral TabletPSNc26391b1-fc43-4e9e-be05-0c47ab6359395
312078olanzapine 5 MG Oral TabletSCDc26391b1-fc43-4e9e-be05-0c47ab6359395

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-1505-35300215050330 TABLET, FILM COATED in 1 BOTTLE (53002-1505-3) 2018-10-010000-00-00NoNoCurrent