NDC Code(s) : 55154-7635-0, 55154-7876-0
Packager : Cardinal Health 107, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Baclofenbaclofen TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-7635(NDC:0904-6475)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN(UNII: H789N3FKE8)
(BACLOFEN - UNII:H789N3FKE8) 		BACLOFEN10 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (white) Score 2 pieces
Shape ROUND (round) Size 9 mm
Flavor Imprint Code LCI;1330
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-7635-010 in 1 BAG 15/07/2015
11 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078220 07/15/2015
Baclofenbaclofen TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-7876(NDC:0904-6476)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACLOFEN(UNII: H789N3FKE8)
(BACLOFEN - UNII:H789N3FKE8) 		BACLOFEN20 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color WHITE (white) Score 2 pieces
Shape ROUND (round) Size 10 mm
Flavor Imprint Code LCI;1337
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55154-7876-010 in 1 BAG 15/07/2015
11 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077241 07/15/2015

LABELER - Cardinal Health 107, LLC(118546603)

PRINCIPAL DISPLAY PANEL

Baclofen Tablets, USP

10 mg

10 Tablets

Bag Label

PRINCIPAL DISPLAY PANEL

Baclofen Tablets, USP

20 mg

10 Tablets

Bag Label