NDC Code(s) : 0378-0825-01, 0378-0825-02, 0378-0972-01, 0378-0972-02, 0378-0860-01, 0378-0860-05, 0378-0860-02, 0378-0860-07, 0378-0973-01, 0378-0973-02
Packager : Mylan Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clozapineclozapine TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-0825
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOZAPINE(UNII: J60AR2IKIC)
(CLOZAPINE - UNII:J60AR2IKIC) 		CLOZAPINE25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 2S7830E561)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color ORANGE (peach) Score 2 pieces
Shape ROUND Size 9 mm
Flavor Imprint Code C;7;M
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-0825-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/08/1999
2NDC:0378-0825-02100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/01/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075417 07/08/1999
Clozapineclozapine TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-0972
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOZAPINE(UNII: J60AR2IKIC)
(CLOZAPINE - UNII:J60AR2IKIC) 		CLOZAPINE50 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 2S7830E561)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color GREEN Score 2 pieces
Shape ROUND Size 6 mm
Flavor Imprint Code C72;M
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-0972-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/04/2010
2NDC:0378-0972-02100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/01/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075417 04/20/2010
Clozapineclozapine TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-0860
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOZAPINE(UNII: J60AR2IKIC)
(CLOZAPINE - UNII:J60AR2IKIC) 		CLOZAPINE100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 2S7830E561)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color GREEN Score 2 pieces
Shape ROUND Size 9 mm
Flavor Imprint Code C11;M
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-0860-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/08/1999
2NDC:0378-0860-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product02/05/2001
3NDC:0378-0860-02100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/01/2020
4NDC:0378-0860-07500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/01/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075417 07/08/1999
Clozapineclozapine TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-0973
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOZAPINE(UNII: J60AR2IKIC)
(CLOZAPINE - UNII:J60AR2IKIC) 		CLOZAPINE200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CROSPOVIDONE(UNII: 2S7830E561)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color GREEN Score 2 pieces
Shape ROUND Size 11 mm
Flavor Imprint Code C73;M
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-0973-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product20/04/2010
2NDC:0378-0973-02100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product10/01/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075417 04/20/2010

LABELER - Mylan Pharmaceuticals Inc.(059295980)

PRINCIPAL DISPLAY PANEL

NDC 0378-0825-01

Clozapine
Tablets, USP
25 mg

Dispensing should be contingent upon ANC
results and should not exceed limits as
specified in the full product labeling.

Rx only      100 Tablets

Each tablet contains:
Clozapine, USP       25 mg

Usual Adult Dosage: See accompanying
prescribing information.

Keep this and all medication out of
the reach of children.

Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

RMXA0825A1

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/AD/089

Clozapine Tablet, USP 25 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 0378-0972-01

Clozapine
Tablets, USP
50 mg

Dispensing should be contingent upon ANC
results and should not exceed limits as
specified in the full product labeling.

Rx only      100 Tablets

Each tablet contains:
Clozapine, USP       50 mg

Usual Adult Dosage: See accompanying
prescribing information.

Keep this and all medication out of
the reach of children.

Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

RMXA0972A1

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/AD/089

Clozapine Tablet, USP 50 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 0378-0860-01

Clozapine
Tablets, USP
100 mg

Dispensing should be contingent upon ANC
results and should not exceed limits as
specified in the full product labeling.

Rx only      100 Tablets

Each tablet contains:
Clozapine, USP       100 mg

Usual Adult Dosage: See accompanying
prescribing information.

Keep this and all medication out of
the reach of children.

Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

RMXA0860A1

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/AD/089

Clozapine Tablet, USP 100 mg Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 0378-0973-01

Clozapine
Tablets, USP
200 mg

Dispensing should be contingent upon ANC
results and should not exceed limits as
specified in the full product labeling.

Rx only      100 Tablets

Each tablet contains:
Clozapine, USP       200 mg

Usual Adult Dosage: See accompanying
prescribing information.

Keep this and all medication out of
the reach of children.

Store at 20° to 25°C (68° to 77°F). [See
USP Controlled Room Temperature.]

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Made in India

Mylan.com

RMXA0973A1

Dispense in a tight, light-resistant
container as defined in the USP
using a child-resistant closure.

Keep container tightly closed.

Code No.: MH/DRUGS/AD/089

Clozapine Tablet, USP 200 mg Bottle Label