Olanzapine

Product NDC
63629-8717
11-digit product format
636298717
Labeler code
63629
Product ID
63629-8717_3363cea7-b182-09e6-e063-6294a90ae027
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091265
Marketing category
ANDA
Marketing start
2011-10-24
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
63629-8717-16362987170130 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63629-8717-1) 2011-10-24NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OlanzapineBryant Ranch Prepack2025-04-22HUMAN PRESCRIPTION DRUG LABEL107