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NDC 71335-0772-01 Quetiapine fumarate 300 mg/1 Details

Quetiapine fumarate 300 mg/1

Quetiapine fumarate is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is QUETIAPINE FUMARATE.

MedlinePlus Drug Summary

Quetiapine tablets and extended-release (long-acting) tablets are 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). Quetiapine tablets and extended-release tablets are also used alone or with other medications to treat episodes of mania (frenzied, abnormally excited or irritated mood) or depression in patients with bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). In addition, quetiapine tablets and extended-release tablets are used with other medications to prevent episodes of mania or depression in patients with bipolar disorder. Quetiapine extended-release tablets are also used along with other medications to treat depression. Quetiapine tablets may be used as part of a treatment program to treat bipolar disorder and schizophrenia in children and teenagers. Quetiapine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Related Packages: 71335-0772-01
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Quetiapine

Product Information

NDC	71335-0772
Product ID	71335-0772_a9bc1e67-05f6-422d-96d8-dd3bb4229e95
Associated GPIs	59153070100340
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	Quetiapine fumarate
Proprietary Name Suffix	n/a
Non-Proprietary Name	Quetiapine fumarate
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, FILM COATED
Route	ORAL
Active Ingredient Strength	300
Active Ingredient Units	mg/1
Substance Name	QUETIAPINE FUMARATE
Labeler Name	Bryant Ranch Prepack
Pharmaceutical Class	Atypical Antipsychotic [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA201190
Listing Certified Through	2024-12-31

Package

NDC 71335-0772-01 (71335077201)

Pricing Information	N/A
NDC Package Code	71335-0772-1
Billing NDC	71335077201
Package	30 TABLET, FILM COATED in 1 BOTTLE (71335-0772-1)
Marketing Start Date	2018-04-11
NDC Exclude Flag	N