Viewing data from:

CLOZAPINE

ANDA

CLOZAPINE | A206433 | AUROBINDO PHARMA LTD

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: CLOZARIL(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 13 NDCs

Highest NADAC/Unit

$0.9160

per ea

Lowest NADAC/Unit

$0.2553

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
65862084701CLOZAPINE 200 MG TABLET	$0.9160	EA	Generic	—	2026-08-19
00904708861CLOZAPINE 200 MG TABLET	$0.9160	EA	Generic	—	2026-08-19
60687042601CLOZAPINE 200 MG TABLET	$0.9160	EA	Generic	—	2026-08-19
65862084601CLOZAPINE 100 MG TABLET	$0.6076	EA	Generic	—	2026-08-19
00904708761CLOZAPINE 100 MG TABLET	$0.6076	EA	Generic	—	2026-08-19
65862084605CLOZAPINE 100 MG TABLET	$0.6076	EA	Generic	—	2026-08-19

Showing 6 of 13 NDCs.

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain12 active DMFs4 inactive

12 active API suppliers hold Drug Master Files for this ingredient.

MEDICHEM SACLOZAPINE

DMF 105341993

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTDCLOZAPINE

DMF 111951994

CAMBREX PROFARMACO MILANO SRLCLOZAPINE

DMF 116921995

WUHAN SHIJI PHARMACEUTICAL CO LTDCLOZAPINE

DMF 198222006

SHOUGUANG FUKANG PHARMACEUTICAL CO LTDCLOZAPINE

DMF 251822011

MATRIX PHARMACORP PRIVATE LTDCLOZAPINE USP

DMF 273792013

COHANCE LIFESCIENCES LTDCLOZAPINE USP

DMF 319992017

AURORE LIFE SCIENCES PRIVATE LTDCLOZAPINE USP

DMF 366452021

GLOBAL CALCIUM PRIVATE LTDCLOZAPINE USP

DMF 368692022

MANKIND PHARMA LTDCLOZAPINE USP

DMF 375402023

R L FINE CHEM PVT LTDCLOZAPINE

DMF 380712023

SMS PHARMACEUTICALS LTDCLOZAPINE USP

DMF 399132024

AREVIPHARMA GMBHInactiveCLOZAPINE

DMF 108621994

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENTInactiveCLOZAPINE

DMF 110981994

SELOC FRANCEInactiveCLOZAPINE

DMF 124011997

HUIZHOU DONGJIANG PHARMACEUTICAL FACTORY GUANGDONGInactiveCLOZAPINE, USP

DMF 128731998

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 6, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 25MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Nov 29, 2016

No patent or exclusivity listings for this strength.

#002 — 50MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 29, 2016

#003 — 100MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 29, 2016

#004 — 200MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Nov 29, 2016