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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
N7U69T4SZROLANZAPINE132539-06-1OLANZAPINE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8243-390061582433930 TABLET, FILM COATED in 1 BLISTER PACK (0615-8243-39) 2018-11-06NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OlanzapineNCS HealthCare of KY, LLC dba Vangard Labs2025-03-03HUMAN PRESCRIPTION DRUG LABEL13