FDA.reportPublic FDA data

Olanzapine

Product NDC
63629-7902
11-digit product format
636297902
Labeler code
63629
Product ID
63629-7902_a87e335a-9f01-4c4d-a1da-c55a843b1dd5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204319
Marketing category
ANDA
Marketing start
2018-01-19
Marketing end
0000-00-00
Substance
OLANZAPINE
Active strength
10 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
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
63629-7902-12024-01-30C16284748780-11030e365-4f18-111a-e063-dadaa90a10e2These 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
63629-7902-22024-01-30C16284748780-11030e365-4f18-111a-e063-dadaa90a10e2These 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
63629-7902-32024-01-30C16284748780-11030e365-4f18-111a-e063-dadaa90a10e2These 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
63629-7902-1Olanzapine30 in 1 BOTTLETABLET304
63629-7902-2Olanzapine60 in 1 BOTTLETABLET604
63629-7902-3Olanzapine90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7902OLANZAPINE TABLET [BRYANT RANCH PREPACK]4Legacy NDC, 3 package rows20220903_78fc032d-d6f4-4953-9a35-ac386f62e232.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314154OLANZapine 10 MG Oral TabletPSN78fc032d-d6f4-4953-9a35-ac386f62e2324
314154olanzapine 10 MG Oral TabletSCD78fc032d-d6f4-4953-9a35-ac386f62e2324

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7902-16362979020130 TABLET in 1 BOTTLE (63629-7902-1) 30 tablet2018-01-190000-00-00NoNoCurrent
63629-7902-26362979020260 TABLET in 1 BOTTLE (63629-7902-2) 60 tablet2021-12-230000-00-00NoNoCurrent
63629-7902-36362979020390 TABLET in 1 BOTTLE (63629-7902-3) 90 tablet2021-12-230000-00-00NoNoCurrent