Olanzapine

Product NDC
63187-364
11-digit product format
631870364
Labeler code
63187
Product ID
63187-364_7af11d56-ef6d-47b7-8119-c30c31ef9cf4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202862
Marketing category
ANDA
Marketing start
2014-08-22
Substance
OLANZAPINE
Active strength
10 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
63187-364-306318703643030 TABLET, FILM COATED in 1 BOTTLE (63187-364-30) 2016-08-01NoNoHistorical
63187-364-606318703646060 TABLET, FILM COATED in 1 BOTTLE (63187-364-60) 2016-08-01NoNoHistorical
63187-364-906318703649090 TABLET, FILM COATED in 1 BOTTLE (63187-364-90) 2016-08-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OlanzapineProficient Rx LP2022-10-01HUMAN PRESCRIPTION DRUG LABEL4