Olanzapine

Product NDC
63187-844
11-digit product format
631870844
Labeler code
63187
Product ID
63187-844_e818889d-6a4e-473d-90cc-f817ffece059
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
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
63187-844-03631870844033 TABLET, FILM COATED in 1 BOTTLE (63187-844-03) 2017-05-01NoNoHistorical
63187-844-306318708443030 TABLET, FILM COATED in 1 BOTTLE (63187-844-30) 2012-04-23NoNoHistorical
63187-844-606318708446060 TABLET, FILM COATED in 1 BOTTLE (63187-844-60) 2012-04-23NoNoHistorical
63187-844-906318708449090 TABLET, FILM COATED in 1 BOTTLE (63187-844-90) 2017-05-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OlanzapineProficient Rx LP2019-11-01HUMAN PRESCRIPTION DRUG LABEL3