Clobazam (Page 9 of 9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clobazam Tablets

Rx Only

10 mg

NDC 68180-157-06

Container label of 30 Tablets

Image-04
(click image for full-size original)

Clobazam Tablets

Rx Only

10 mg

NDC 68180-157-06

Carton label of 30 Tablets

image-05
(click image for full-size original)

Clobazam Tablets

Rx Only

20 mg

NDC 68180-158-06

Container label of 30 Tablets

image-06
(click image for full-size original)

Clobazam Tablets

Rx Only

20 mg

NDC 68180-158-06

Carton label of 30 Tablets

image-07
(click image for full-size original)
CLOBAZAM clobazam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-157
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
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
Product Characteristics
Color WHITE (off-white) Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code L;7
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-157-09 1 BOTTLE in 1 CARTON contains a BOTTLE
1 90 TABLET in 1 BOTTLE This package is contained within the CARTON (68180-157-09)
2 NDC:68180-157-01 1 BOTTLE in 1 CARTON contains a BOTTLE
2 100 TABLET in 1 BOTTLE This package is contained within the CARTON (68180-157-01)
3 NDC:68180-157-02 1 BOTTLE in 1 CARTON contains a BOTTLE
3 500 TABLET in 1 BOTTLE This package is contained within the CARTON (68180-157-02)
4 NDC:68180-157-06 1 BOTTLE in 1 CARTON contains a BOTTLE
4 30 TABLET in 1 BOTTLE This package is contained within the CARTON (68180-157-06)
5 NDC:68180-157-07 1 BOTTLE in 1 CARTON contains a BOTTLE
5 60 TABLET in 1 BOTTLE This package is contained within the CARTON (68180-157-07)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210545 05/08/2019
CLOBAZAM clobazam tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68180-158
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
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
Product Characteristics
Color WHITE (off-white) Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code L;8
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68180-158-09 1 BOTTLE in 1 CARTON contains a BOTTLE
1 90 TABLET in 1 BOTTLE This package is contained within the CARTON (68180-158-09)
2 NDC:68180-158-01 1 BOTTLE in 1 CARTON contains a BOTTLE
2 100 TABLET in 1 BOTTLE This package is contained within the CARTON (68180-158-01)
3 NDC:68180-158-02 1 BOTTLE in 1 CARTON contains a BOTTLE
3 500 TABLET in 1 BOTTLE This package is contained within the CARTON (68180-158-02)
4 NDC:68180-158-06 1 BOTTLE in 1 CARTON contains a BOTTLE
4 30 TABLET in 1 BOTTLE This package is contained within the CARTON (68180-158-06)
5 NDC:68180-158-07 1 BOTTLE in 1 CARTON contains a BOTTLE
5 60 TABLET in 1 BOTTLE This package is contained within the CARTON (68180-158-07)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210545 05/08/2019
Labeler — Lupin Pharmaceuticals, Inc. (089153071)
Registrant — LUPIN LIMITED (675923163)
Establishment
Name Address ID/FEI Operations
LUPIN LIMITED 650759348 MANUFACTURE (68180-157), MANUFACTURE (68180-158), PACK (68180-157), PACK (68180-158)

Revised: 05/2021 Lupin Pharmaceuticals, Inc.

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