Olanzapine

Product NDC
14445-107
11-digit product format
144450107
Labeler code
14445
Product ID
14445-107_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
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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14445-107-00Olanzapine1000 in 1 BOTTLETABLET10001
14445-107-10Olanzapine100 in 1 BLISTER PACKTABLET1001
14445-107-30Olanzapine30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
14445-107OLANZAPINE 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
14445-107-00144450107001000 TABLET in 1 BOTTLE (14445-107-00) 1000 tablet2020-08-140000-00-00NoNoCurrent
14445-107-1014445010710100 TABLET in 1 BLISTER PACK (14445-107-10) 100 tablet2020-08-140000-00-00NoNoCurrent
14445-107-301444501073030 TABLET in 1 BOTTLE (14445-107-30) 30 tablet2020-08-140000-00-00NoNoCurrent