FDA.reportPublic FDA data

Olanzapine

Product NDC
67046-522
11-digit product format
670460522
Labeler code
67046
Product ID
67046-522_5a1dc228-b758-5f2b-e053-2991aa0adccc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA090798
Marketing category
ANDA
Marketing start
2017-09-26
Marketing end
0000-00-00
Substance
OLANZAPINE
Active strength
5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2019-12-31
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
67046-522-072020-01-31C16284748780-19d75b9d0-e3fe-f424-e053-dadaa90a57ce522 Olanzapine 5 mg 523 Olanzapine 15 mg These 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
67046-522-142020-01-31C16284748780-19d75b9d0-e3fe-f424-e053-dadaa90a57ce522 Olanzapine 5 mg 523 Olanzapine 15 mg These 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
67046-522-152020-01-31C16284748780-19d75b9d0-e3fe-f424-e053-dadaa90a57ce522 Olanzapine 5 mg 523 Olanzapine 15 mg These 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
67046-522-202020-01-31C16284748780-19d75b9d0-e3fe-f424-e053-dadaa90a57ce522 Olanzapine 5 mg 523 Olanzapine 15 mg These 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
67046-522-212020-01-31C16284748780-19d75b9d0-e3fe-f424-e053-dadaa90a57ce522 Olanzapine 5 mg 523 Olanzapine 15 mg These 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
67046-522-282020-01-31C16284748780-19d75b9d0-e3fe-f424-e053-dadaa90a57ce522 Olanzapine 5 mg 523 Olanzapine 15 mg These 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
67046-522-302020-01-31C16284748780-19d75b9d0-e3fe-f424-e053-dadaa90a57ce522 Olanzapine 5 mg 523 Olanzapine 15 mg These 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
67046-522-602020-01-31C16284748780-19d75b9d0-e3fe-f424-e053-dadaa90a57ce522 Olanzapine 5 mg 523 Olanzapine 15 mg These 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
67046-522-07Olanzapine7 in 1 BLISTER PACKTABLET, FILM COATED71
67046-522-14Olanzapine14 in 1 BLISTER PACKTABLET, FILM COATED141
67046-522-15Olanzapine15 in 1 BLISTER PACKTABLET, FILM COATED151
67046-522-20Olanzapine20 in 1 BLISTER PACKTABLET, FILM COATED201
67046-522-21Olanzapine21 in 1 BLISTER PACKTABLET, FILM COATED211
67046-522-28Olanzapine28 in 1 BLISTER PACKTABLET, FILM COATED281
67046-522-30Olanzapine30 in 1 BLISTER PACKTABLET, FILM COATED301
67046-522-60Olanzapine60 in 1 BLISTER PACKTABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-522OLANZAPINE TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170927_5a1dc228-b757-5f2b-e053-2991aa0adccc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312077OLANZapine 15 MG Oral TabletPSN5a1dc228-b757-5f2b-e053-2991aa0adccc1
312078OLANZapine 5 MG Oral TabletPSN5a1dc228-b757-5f2b-e053-2991aa0adccc1
312077olanzapine 15 MG Oral TabletSCD5a1dc228-b757-5f2b-e053-2991aa0adccc1
312078olanzapine 5 MG Oral TabletSCD5a1dc228-b757-5f2b-e053-2991aa0adccc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67046-522-07670460522077 in 1 BLISTER PACKHistorical
67046-522-146704605221414 in 1 BLISTER PACKHistorical
67046-522-156704605221515 in 1 BLISTER PACKHistorical
67046-522-206704605222020 in 1 BLISTER PACKHistorical
67046-522-216704605222121 in 1 BLISTER PACKHistorical
67046-522-286704605222828 in 1 BLISTER PACKHistorical
67046-522-306704605223030 in 1 BLISTER PACKHistorical
67046-522-606704605226060 in 1 BLISTER PACKHistorical