Clonazepam (Page 7 of 7)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 0.125 mg — 60 Tablets

PDP-0.125mg
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 0.25 mg — 60 Tablets

PDP-0.25mg
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 0.5 mg — 60 Tablets

PDP-0.5mg
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 1 mg — 60 Tablets

PDP-1mg
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PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 2 mg — 60 Tablets

PDP-2mg
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CLONAZEPAM
clonazepam tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-783
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONAZEPAM (CLONAZEPAM) CLONAZEPAM 0.125 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
CROSPOVIDONE (15 MPA.S AT 5%)
STARCH, CORN
ASPARTAME
TALC
MAGNESIUM STEARATE
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 1;8;C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57664-783-83 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
2 NDC:57664-783-86 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
3 NDC:57664-783-88 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078654 03/29/2017
CLONAZEPAM
clonazepam tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-784
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONAZEPAM (CLONAZEPAM) CLONAZEPAM 0.25 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
CROSPOVIDONE (15 MPA.S AT 5%)
STARCH, CORN
ASPARTAME
TALC
MAGNESIUM STEARATE
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 1;4;C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57664-784-83 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
2 NDC:57664-784-86 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
3 NDC:57664-784-88 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078654 03/29/2017
CLONAZEPAM
clonazepam tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-785
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONAZEPAM (CLONAZEPAM) CLONAZEPAM 0.5 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
CROSPOVIDONE (15 MPA.S AT 5%)
STARCH, CORN
ASPARTAME
TALC
MAGNESIUM STEARATE
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 1;2;C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57664-785-83 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
2 NDC:57664-785-86 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
3 NDC:57664-785-88 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078654 03/29/2017
CLONAZEPAM
clonazepam tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-786
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONAZEPAM (CLONAZEPAM) CLONAZEPAM 1 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
CROSPOVIDONE (15 MPA.S AT 5%)
STARCH, CORN
ASPARTAME
TALC
MAGNESIUM STEARATE
Product Characteristics
Color white (white to off-white) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 1;C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57664-786-83 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
2 NDC:57664-786-86 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
3 NDC:57664-786-88 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078654 03/29/2017
CLONAZEPAM
clonazepam tablet, orally disintegrating
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-787
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLONAZEPAM (CLONAZEPAM) CLONAZEPAM 2 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
CROSPOVIDONE (15 MPA.S AT 5%)
STARCH, CORN
ASPARTAME
TALC
MAGNESIUM STEARATE
Product Characteristics
Color white (white to off-white) Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 2;C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57664-787-83 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
2 NDC:57664-787-86 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
3 NDC:57664-787-88 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078654 03/29/2017
Labeler — Sun Pharmaceutical Industries, Inc. (146974886)
Establishment
Name Address ID/FEI Operations
Sun Pharmaceutical Industries Limited 650456002 MANUFACTURE (57664-783), MANUFACTURE (57664-784), MANUFACTURE (57664-785), MANUFACTURE (57664-786), MANUFACTURE (57664-787)

Revised: 02/2023 Sun Pharmaceutical Industries, Inc.

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