Baclofen (Page 2 of 2)

HOW SUPPLIED

Baclofen Tablets USP, 10 mg are available as a white, round, flat-faced, beveled-edge tablet debossed with “4096” on one side and “TV” with a partial score on the other side, containing 10 mg Baclofen USP packaged in blistercards of 15, 30 and 31 tablets.

Baclofen Tablets USP, 20 mg are available as a white, round, flat-faced, beveled-edge tablet debossed with “4097” on one side and “TV” with a partial score on the other side, containing 20 mg Baclofen USP packaged in blistercards of 30 and 31 tablets.

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].

Rev. A 5/2010

Manufactured In Croatia By:

PLIVA HRVATSKA d.o.o.

Zagreb, Croatia

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

BACLOFEN TABLETS USP

PRINCIPAL DISPLAY PANEL

Baclofen Tablets,

USP 10mg

Principal Display Panel-Baclofen Tablets 10mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Baclofen Tablets,

USP 20mg

Principal Display Panel-Baclofen Tablets, USP 20mg
(click image for full-size original)
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-3541(NDC:0172-4096)
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
ANHYDROUS LACTOSE
SILICON DIOXIDE
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (white to off white) Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code 4096;TV
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0615-3541-05 15 TABLET in 1 BLISTER PACK None
2 NDC:0615-3541-31 31 TABLET in 1 BLISTER PACK None
3 NDC:0615-3541-39 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072234 07/15/2010
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-3542(NDC:0172-4097)
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
ANHYDROUS LACTOSE
SILICON DIOXIDE
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
Product Characteristics
Color WHITE (white to off white) Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code 4097;TV
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0615-3542-31 31 TABLET in 1 BLISTER PACK None
2 NDC:0615-3542-39 30 TABLET in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072235 07/15/2010
Labeler — NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
Name Address ID/FEI Operations
NCS HealthCare of KY, Inc dba Vangard Labs 050052943 REPACK (0615-3541), REPACK (0615-3542)

Revised: 09/2015 NCS HealthCare of KY, Inc dba Vangard Labs

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