Olanzapine

Product NDC
71205-487
11-digit product format
712050487
Labeler code
71205
Product ID
71205-487_61424fa3-b09a-4267-a208-a7c7c3f69fe5
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
15 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
71205-487-307120504873030 TABLET, FILM COATED in 1 BOTTLE (71205-487-30) 2020-10-16NoNoHistorical
71205-487-607120504876060 TABLET, FILM COATED in 1 BOTTLE (71205-487-60) 2020-10-16NoNoHistorical
71205-487-907120504879090 TABLET, FILM COATED in 1 BOTTLE (71205-487-90) 2020-10-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
OlanzapineProficient Rx LP2020-10-01HUMAN PRESCRIPTION DRUG LABEL1