Olanzapine

Product NDC
72603-159
11-digit product format
726030159
Labeler code
72603
Product ID
72603-159_bfaf4fef-69a8-40e1-b995-899044ad4a39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olanzapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA202862
Marketing category
ANDA
Marketing start
2023-07-05
Substance
OLANZAPINE
Active strength
20 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
72603-159-017260301590130 TABLET, FILM COATED in 1 BOTTLE (72603-159-01) 2023-07-05NoNoHistorical
72603-159-0272603015902500 TABLET, FILM COATED in 1 BOTTLE (72603-159-02) 2023-07-05NoNoHistorical
72603-159-03726030159031000 TABLET, FILM COATED in 1 BOTTLE (72603-159-03) 2023-07-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OlanzapineNorthStar RxLLC | Macleods Pharmaceuticals Limited2024-07-03Human Prescription Drug Label2