Clobazam (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42571-315-01
Clobazam Tablets CIV
10 mg
DISPENSE THE ENCLOSED MEDICATION GUIDE
WITH EACH PRESCRIPTION
Rx Only
100 Tablets Micro Labs Limited

//medlibrary.org/lib/images-rx/clobazam-19/clobazam-lbl-a-300x113.jpg
(click image for full-size original)

NDC 42571-316-01
Clobazam Tablets CIV
20 mg
DISPENSE THE ENCLOSED MEDICATION GUIDE
WITH EACH PRESCRIPTION
Rx Only
100 Tablets Micro Labs Limited

//medlibrary.org/lib/images-rx/clobazam-19/clobazam-lbl-b-300x116.jpg
(click image for full-size original)
CLOBAZAM clobazam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-315
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOBAZAM (CLOBAZAM) CLOBAZAM 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
ANHYDROUS LACTOSE
SILICON DIOXIDE
TALC
MAGNESIUM STEARATE
Product Characteristics
Color white (White to off white) Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code 1;0
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42571-315-30 30 TABLET in 1 BOTTLE None
2 NDC:42571-315-90 90 TABLET in 1 BOTTLE None
3 NDC:42571-315-05 500 TABLET in 1 BOTTLE None
4 NDC:42571-315-11 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (42571-315-32)
4 NDC:42571-315-32 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (42571-315-11)
5 NDC:42571-315-91 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (42571-315-20)
5 NDC:42571-315-20 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (42571-315-91)
6 NDC:42571-315-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211711 04/02/2019
CLOBAZAM clobazam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42571-316
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOBAZAM (CLOBAZAM) CLOBAZAM 20 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
ANHYDROUS LACTOSE
SILICON DIOXIDE
TALC
MAGNESIUM STEARATE
Product Characteristics
Color white (White to off-white) Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code 2;0
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42571-316-30 30 TABLET in 1 BOTTLE None
2 NDC:42571-316-90 90 TABLET in 1 BOTTLE None
3 NDC:42571-316-11 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (42571-316-32)
3 NDC:42571-316-32 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (42571-316-11)
4 NDC:42571-316-91 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (42571-316-20)
4 NDC:42571-316-20 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (42571-316-91)
5 NDC:42571-316-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211711 04/02/2019
Labeler — Micro Labs Limited (862174955)
Establishment
Name Address ID/FEI Operations
Micro Labs Limited 915793658 analysis (42571-315), analysis (42571-316), label (42571-315), label (42571-316), manufacture (42571-315), manufacture (42571-316), pack (42571-315), pack (42571-316)

Revised: 03/2024 Micro Labs Limited

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