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NDC 00378-3817-01 Clozapine 200 mg/1 Details

Clozapine 200 mg/1

Clozapine is a ORAL TABLET, ORALLY DISINTEGRATING in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is CLOZAPINE.

MedlinePlus Drug Summary

Clozapine 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 people who have not been helped by other medications or who have tried to kill themselves and are likely to try to kill or harm themselves again. Clozapine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Related Packages: 00378-3817-01
Last Updated: 03/24/2024
MedLinePlus Full Drug Details: Clozapine

Product Information

NDC	00378-3817
Product ID	0378-3817_47227a5a-7480-4106-9051-b3dac7de31f4
Associated GPIs
GCN Sequence Number	066558
GCN Sequence Number Description	clozapine TAB RAPDIS 200 MG ORAL
HIC3	H7T
HIC3 Description	ANTIPSYCHOTIC,ATYPICAL,DOPAMINE,SEROTONIN ANTAGNST
GCN	28874
HICL Sequence Number	004834
HICL Sequence Number Description	CLOZAPINE
Brand/Generic	Generic
Proprietary Name	Clozapine
Proprietary Name Suffix	n/a
Non-Proprietary Name	clozapine
Product Type	HUMAN PRESCRIPTION DRUG
Dosage Form	TABLET, ORALLY DISINTEGRATING
Route	ORAL
Active Ingredient Strength	200
Active Ingredient Units	mg/1
Substance Name	CLOZAPINE
Labeler Name	Mylan Pharmaceuticals Inc.
Pharmaceutical Class	Atypical Antipsychotic [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA201824
Listing Certified Through	2024-12-31

Package

NDC 00378-3817-01 (00378381701)

Pricing Information	N/A
NDC Package Code	0378-3817-01
Billing NDC	00378381701
Package	100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-3817-01)
Marketing Start Date	2023-08-16
NDC Exclude Flag	N