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

bottles of 30 NDC 54868-3405-0
bottles of 60 NDC 54868-3405-2
bottles of 90 NDC 54868-3405-3
bottles of 100 NDC 54868-3405-5

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

bottles of 30 NDC 54868-3006-4
bottles of 60 NDC 54868-3006-1
bottles of 90 NDC 54868-3006-3
bottles of 120 NDC 54868-3006-6

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



Distributed by:
Physicians Total Care, Inc.
Tulsa, OK 74146

PRINCIPAL DISPLAY PANEL

Baclofen Tablets USP 10 mg
(click image for full-size original)

Baclofen Tablets USP 10 mg Label Text


BACLOFEN
Tablets USP10 mg

Rx only

PRINCIPAL DISPLAY PANEL

Baclofen Tablets USP 20 mg
(click image for full-size original)

Baclofen Tablets USP 20 mg Label Text


BACLOFEN
Tablets USP20 mg

Rx only

BACLOFEN baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-3405(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:54868-3405-0 30 TABLET in 1 BOTTLE None
2 NDC:54868-3405-2 60 TABLET in 1 BOTTLE None
3 NDC:54868-3405-3 90 TABLET (TABLET) in 1 BOTTLE None
4 NDC:54868-3405-5 100 TABLET (TABLET) in 1 BOTTLE None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072234 03/05/2010
BACLOFEN baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-3006(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:54868-3006-1 60 TABLET in 1 BOTTLE None
2 NDC:54868-3006-3 90 TABLET in 1 BOTTLE None
3 NDC:54868-3006-4 30 TABLET (TABLET) in 1 BOTTLE None
4 NDC:54868-3006-6 120 TABLET (TABLET) in 1 BOTTLE None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA072235 04/17/2009
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel (54868-3405), repack (54868-3405), relabel (54868-3006), repack (54868-3006)

Revised: 02/2014 Physicians Total Care, Inc.

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