Olanzapine

Product NDC
0615-8243
11-digit product format
006158243
Labeler code
0615
Product ID
0615-8243_23d2c50e-1be1-4357-bb2f-a9903ba4a43b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA202862
Marketing category
ANDA
Marketing start
2014-08-22
Substance
OLANZAPINE
Active strength
2.5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Olanzapine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLANZAPINE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN7U69T4SZR
Rxcui200034, 283639, 312077, 312078, 314154

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8243-39Olanzapine30 in 1 BLISTER PACKTABLET, FILM COATED3013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8243OLANZAPINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]13Current NDC, Legacy NDC, 1 package rows20250305_87b7fb23-c9b7-433f-bd17-cd3e91714c27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314154OLANZapine 10 MG Oral TabletPSN87b7fb23-c9b7-433f-bd17-cd3e91714c2713
312077OLANZapine 15 MG Oral TabletPSN87b7fb23-c9b7-433f-bd17-cd3e91714c2713
200034OLANZapine 2.5 MG Oral TabletPSN87b7fb23-c9b7-433f-bd17-cd3e91714c2713
283639OLANZapine 20 MG Oral TabletPSN87b7fb23-c9b7-433f-bd17-cd3e91714c2713
312078OLANZapine 5 MG Oral TabletPSN87b7fb23-c9b7-433f-bd17-cd3e91714c2713
314154olanzapine 10 MG Oral TabletSCD87b7fb23-c9b7-433f-bd17-cd3e91714c2713
312077olanzapine 15 MG Oral TabletSCD87b7fb23-c9b7-433f-bd17-cd3e91714c2713
200034olanzapine 2.5 MG Oral TabletSCD87b7fb23-c9b7-433f-bd17-cd3e91714c2713
283639olanzapine 20 MG Oral TabletSCD87b7fb23-c9b7-433f-bd17-cd3e91714c2713
312078olanzapine 5 MG Oral TabletSCD87b7fb23-c9b7-433f-bd17-cd3e91714c2713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0615-8243-390061582433930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8243-39) 2018-11-060000-00-00NoNoCurrent