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NDC 53002-1505-03 Olanzapine 5 mg/1 Details

Olanzapine 5 mg/1

Olanzapine is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by RPK Pharmaceuticals, Inc.. The primary component is OLANZAPINE.

MedlinePlus Drug Summary

Olanzapine is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) in adults and teenagers 13 years of age and older. It is also used to treat bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods) in adults and teenagers 13 years of age and older. Olanzapine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Related Packages: 53002-1505-03
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Olanzapine

Product Information

NDC	53002-1505
Product ID	53002-1505_c46a6a41-3994-4f96-8faf-97d18b5f7d63
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Olanzapine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Olanzapine
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	5
Active Ingredient Units	mg/1
Substance Name	OLANZAPINE
Labeler Name	RPK Pharmaceuticals, Inc.
Pharmaceutical Class	Atypical Antipsychotic [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA090798
Listing Certified Through	2024-12-31

Package

NDC 53002-1505-03 (53002150503)

Pricing Information	N/A
NDC Package Code	53002-1505-3
Billing NDC	53002150503
Package	30 TABLET, FILM COATED in 1 BOTTLE (53002-1505-3)
Marketing Start Date	2018-10-01
NDC Exclude Flag	N