FDA.reportPublic FDA data

Olanzapine

Product NDC
14445-111
11-digit product format
144450111
Labeler code
14445
Product ID
14445-111_5b7d091a-7e7a-46ac-ab13-49ef27b1b0a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET
Route
ORAL
Labeler
Indoco Remedies Limited
Application
ANDA206155
Marketing category
ANDA
Marketing start
2020-08-14
Marketing end
0000-00-00
Substance
OLANZAPINE
Active strength
20 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
14445-111-002026-01-29C16284748780-149896155-c67a-586f-e063-e6dba90add90HIGHLIGHTS OF PRESCRIBING INFORMATION 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
14445-111-102026-01-29C16284748780-149896155-c67a-586f-e063-e6dba90add90HIGHLIGHTS OF PRESCRIBING INFORMATION 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
14445-111-302026-01-29C16284748780-149896155-c67a-586f-e063-e6dba90add90HIGHLIGHTS OF PRESCRIBING INFORMATION 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
14445-111-00Olanzapine1000 in 1 BOTTLETABLET10001
14445-111-10Olanzapine100 in 1 BLISTER PACKTABLET1001
14445-111-30Olanzapine30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14445-111OLANZAPINE TABLET [INDOCO REMEDIES LIMITED ]1Legacy NDC, 3 package rows20200815_5b7d091a-7e7a-46ac-ab13-49ef27b1b0a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314154OLANZapine 10 MG Oral TabletPSN5b7d091a-7e7a-46ac-ab13-49ef27b1b0a51
312077OLANZapine 15 MG Oral TabletPSN5b7d091a-7e7a-46ac-ab13-49ef27b1b0a51
200034OLANZapine 2.5 MG Oral TabletPSN5b7d091a-7e7a-46ac-ab13-49ef27b1b0a51
283639OLANZapine 20 MG Oral TabletPSN5b7d091a-7e7a-46ac-ab13-49ef27b1b0a51
312078OLANZapine 5 MG Oral TabletPSN5b7d091a-7e7a-46ac-ab13-49ef27b1b0a51
312079OLANZapine 7.5 MG Oral TabletPSN5b7d091a-7e7a-46ac-ab13-49ef27b1b0a51
314154olanzapine 10 MG Oral TabletSCD5b7d091a-7e7a-46ac-ab13-49ef27b1b0a51
312077olanzapine 15 MG Oral TabletSCD5b7d091a-7e7a-46ac-ab13-49ef27b1b0a51
200034olanzapine 2.5 MG Oral TabletSCD5b7d091a-7e7a-46ac-ab13-49ef27b1b0a51
283639olanzapine 20 MG Oral TabletSCD5b7d091a-7e7a-46ac-ab13-49ef27b1b0a51
312078olanzapine 5 MG Oral TabletSCD5b7d091a-7e7a-46ac-ab13-49ef27b1b0a51
312079olanzapine 7.5 MG Oral TabletSCD5b7d091a-7e7a-46ac-ab13-49ef27b1b0a51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
14445-111-00144450111001000 TABLET in 1 BOTTLE (14445-111-00) 1000 tablet2020-08-140000-00-00NoNoCurrent
14445-111-1014445011110100 TABLET in 1 BLISTER PACK (14445-111-10) 100 tablet2020-08-140000-00-00NoNoCurrent
14445-111-301444501113030 TABLET in 1 BOTTLE (14445-111-30) 30 tablet2020-08-140000-00-00NoNoCurrent