Viewing data from:

CLOZAPINE

ANDA

CLOZAPINE | A075417 | MYLAN PHARMACEUTICALS INC

5 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: CLOZARIL(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 8 NDCs

Highest NADAC/Unit

$0.9628

per ea

Lowest NADAC/Unit

$0.2479

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
51079074920CLOZAPINE 200 MG TABLET	$0.9628	EA	Generic	—	2026-06-17
00378097301CLOZAPINE 200 MG TABLET	$0.9628	EA	Generic	—	2026-06-17
00378086005CLOZAPINE 100 MG TABLET	$0.6134	EA	Generic	—	2026-06-17
51079092220CLOZAPINE 100 MG TABLET	$0.6134	EA	Generic	—	2026-06-17
00378086001CLOZAPINE 100 MG TABLET	$0.6134	EA	Generic	—	2026-06-17
00378097201CLOZAPINE 50 MG TABLET	$0.5387	EA	Generic	—	2026-06-17
51079092120CLOZAPINE 25 MG TABLET	$0.2479	EA	Generic	—	2026-06-17
00378082501CLOZAPINE 25 MG TABLET	$0.2479	EA	Generic	—	2026-06-17

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

VA Federal Supply Schedule

Government-negotiated contract prices | 5 NDCs, 5 NC)

Lowest Price

$19.05

Highest Price

$217.50

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00378-0825-01CLOZAPINE (MYLAN) 25MG TAB	$19.05	NC	Mylan Pharmaceuticals Inc.	03/03/2027
00378-0860-01CLOZAPINE (MYLAN) 100MG TAB	$48.34	NC	Mylan Pharmaceuticals Inc.	03/03/2027
00378-0860-05CLOZAPINE (MYLAN) 100MG TAB	$217.50	NC	Mylan Pharmaceuticals Inc.	03/03/2027
00378-0972-01CLOZAPINE (MYLAN) 50MG TAB	$57.03	NC	Mylan Pharmaceuticals Inc.	03/03/2027
00378-0973-01CLOZAPINE (MYLAN) 200MG TAB	$141.54	NC	Mylan Pharmaceuticals Inc.	03/03/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

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

4 letters from Drugs@FDA

Date	Submission	Document
Apr 28, 2010	SUPPL -21	View Letter (PDF)
Apr 28, 2010	SUPPL -24	View Letter (PDF)
Apr 28, 2010	SUPPL -25	View Letter (PDF)
May 27, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (5)

Sort:

#001 — 25MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 27, 1999

No patent or exclusivity listings for this strength.

#002 — 100MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 27, 1999

#003 — 12.5MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 15, 2010

#004 — 50MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 15, 2010

#005 — 200MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Apr 15, 2010