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 in bottles of 100 (NDC 0527-1330-01), 500 (NDC 0527-1330-05) and 1000 (NDC 0527-1330-10).

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 in bottles of 100 (NDC 0527-1337-01) and 500 (NDC 0527-1337-05).

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].

Distributed by:

Lannett Company, Inc.

Philadelphia, PA 19136

Made in the USA

CIB70280B

Rev. 03/16

PRINCIPAL DISPLAY PANEL — 20 mg

pdp
(click image for full-size original)

BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45865-355(NDC:0527-1337)
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
CELLULOSE, MICROCRYSTALLINE
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:45865-355-51 120 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077241 12/01/2005
Labeler — Medsource Pharmaceuticals (833685915)
Establishment
Name Address ID/FEI Operations
medsource pharmaceuticals 833685915 repack (45865-355)

Revised: 12/2019 Medsource Pharmaceuticals

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