NDC Code(s) : 49884-306-02, 49884-307-02, 49884-308-02, 49884-309-02, 49884-310-02
Packager : Par Pharmaceutical, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CIV

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clonazepamclonazepam TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-306
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONAZEPAM(UNII: 5PE9FDE8GB)
(CLONAZEPAM - UNII:5PE9FDE8GB) 		CLONAZEPAM0.125 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
CROSPOVIDONE(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SORBITOL(UNII: 506T60A25R)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color white Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code K5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49884-306-0260 in 1 BLISTER PACK Type 0: Not a Combination Product08/05/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077171 08/05/2005
Clonazepamclonazepam TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-307
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONAZEPAM(UNII: 5PE9FDE8GB)
(CLONAZEPAM - UNII:5PE9FDE8GB) 		CLONAZEPAM.25 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
CROSPOVIDONE(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SORBITOL(UNII: 506T60A25R)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color white Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code K6
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49884-307-0260 in 1 BLISTER PACK Type 0: Not a Combination Product08/05/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077171 08/05/2005
Clonazepamclonazepam TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-308
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONAZEPAM(UNII: 5PE9FDE8GB)
(CLONAZEPAM - UNII:5PE9FDE8GB) 		CLONAZEPAM.5 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
CROSPOVIDONE(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SORBITOL(UNII: 506T60A25R)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color white Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code K7
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49884-308-0260 in 1 BLISTER PACK Type 0: Not a Combination Product08/05/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077171 08/05/2005
Clonazepamclonazepam TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-309
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONAZEPAM(UNII: 5PE9FDE8GB)
(CLONAZEPAM - UNII:5PE9FDE8GB) 		CLONAZEPAM1 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
CROSPOVIDONE(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SORBITOL(UNII: 506T60A25R)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color white Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code K8
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49884-309-0260 in 1 BLISTER PACK Type 0: Not a Combination Product08/05/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077171 08/05/2005
Clonazepamclonazepam TABLET, ORALLY DISINTEGRATING
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-310
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONAZEPAM(UNII: 5PE9FDE8GB)
(CLONAZEPAM - UNII:5PE9FDE8GB) 		CLONAZEPAM2 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
CROSPOVIDONE(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SORBITOL(UNII: 506T60A25R)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color white Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code K9
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49884-310-0260 in 1 BLISTER PACK Type 0: Not a Combination Product08/05/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077171 08/05/2005

LABELER - Par Pharmaceutical, Inc.(092733690)

REGISTRANT - Par Pharmaceutical Inc.(092733690)

PRINCIPAL DISPLAY PANEL

Clonazepam ODT, USP 0.125 mg - BlisterClonazepam ODT, USP 0.125 mg - Blister Clonazepam ODT, USP 0.125 mg - BlisterClonazepam ODT, USP 0.125 mg - Blister

PRINCIPAL DISPLAY PANEL

Clonazepam ODT, USP 0.25 mg - BlisterClonazepam ODT, USP 0.25 mg - Blister Clonazepam ODT, USP 0.25 mg - BlisterClonazepam ODT, USP 0.25 mg - Blister

PRINCIPAL DISPLAY PANEL

Clonazepam ODT, USP 0.5 mg - BlisterClonazepam ODT, USP 0.5 mg - Blister

PRINCIPAL DISPLAY PANEL

Clonazepam ODT, USP 1 mg - BlisterClonazepam ODT, USP 1 mg - Blister

PRINCIPAL DISPLAY PANEL

Clonazepam ODT, USP 2 mg - BlisterClonazepam ODT, USP 2 mg - Blister Clonazepam ODT, USP 2 mg - BlisterClonazepam ODT, USP 2 mg - Blister

PRINCIPAL DISPLAY PANEL

This is the 0.125 mg cartonThis is the 0.125 mg carton0.125 mg carton

PRINCIPAL DISPLAY PANEL

This is the 0.25 mg carton.This is the 0.25 mg carton.0.25 mg carton.

PRINCIPAL DISPLAY PANEL

This is the 0.5 mg carton

PRINCIPAL DISPLAY PANEL

This is the 1 mg carton

PRINCIPAL DISPLAY PANEL

This is the 2 mg cartonThis is the 2 mg carton2 mg carton