Olanzapine

Product NDC
63187-340
11-digit product format
631870340
Labeler code
63187
Product ID
63187-340_c6e1cbe2-4d81-4b7c-b948-d64d9b3527a7
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
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
63187-340-06631870340066 TABLET, FILM COATED in 1 BOTTLE (63187-340-06) 2023-02-21NoNoHistorical
63187-340-306318703403030 TABLET, FILM COATED in 1 BOTTLE (63187-340-30) 2015-02-02NoNoHistorical
63187-340-606318703406060 TABLET, FILM COATED in 1 BOTTLE (63187-340-60) 2023-02-21NoNoHistorical
63187-340-906318703409090 TABLET, FILM COATED in 1 BOTTLE (63187-340-90) 2023-02-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OlanzapineProficient Rx LP2023-02-01HUMAN PRESCRIPTION DRUG LABEL5