Baclofen (Page 2 of 2)

HOW SUPPLIED

Baclofen Tablets USP, 10 mg are available as a white round flat-faced beveled edge bisected tablet debossed with “LCI” over “1330″ on one side and plain on the other side, containing 10 mg Baclofen USP. Available overbagged with 10 tablets per bag, NDC 55154-7635-0.

Baclofen Tablets USP, 20 mg are available as a white round flat-faced beveled edge bisected tablet debossed with “LCI” over “1337″ on one side and plain on the other side, containing 20 mg Baclofen USP. Available overbagged with 10 tablets per bag, NDC 55154-7876-0.

PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Manufactured by:
LANNETT COMPANY, INC.
Philadelphia, PA 19136
Made in the USA

Distributed by:
MAJOR PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA

Rev. 04/14, Revision 1

10-322

Package/Label Display Panel

Baclofen Tablets, USP

10 mg

10 Tablets

bag label
(click image for full-size original)

Package/Label Display Panel

Baclofen Tablets, USP

20 mg

10 Tablets

bag label
(click image for full-size original)
BACLOFEN
baclofen 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 (BACLOFEN) BACLOFEN 10 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (white) Score 2 pieces
Shape ROUND (round) Size 9mm
Flavor Imprint Code LCI;1330
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-7635-0 10 BLISTER PACK in 1 BAG contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the BAG (55154-7635-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078220 07/15/2015
BACLOFEN
baclofen 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 (BACLOFEN) BACLOFEN 20 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SILICON DIOXIDE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (white) Score 2 pieces
Shape ROUND (round) Size 10mm
Flavor Imprint Code LCI;1337
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-7876-0 10 BLISTER PACK in 1 BAG contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the BAG (55154-7876-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077241 07/15/2015
Labeler — Cardinal Health (188557102)
Establishment
Name Address ID/FEI Operations
Cardinal Health 188557102 REPACK (55154-7635), REPACK (55154-7876)

Revised: 05/2017 Cardinal Health

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