Olanzapine

Product NDC
63187-453
11-digit product format
631870453
Labeler code
63187
Product ID
63187-453_46cd719f-a6bc-4b3b-8ef5-860896fb787d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090798
Marketing category
ANDA
Marketing start
2012-04-23
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
63187-453-306318704533030 TABLET, FILM COATED in 1 BOTTLE (63187-453-30) 2015-02-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OlanzapineProficient Rx LP2021-01-01HUMAN PRESCRIPTION DRUG LABEL4