Baclofen (Page 2 of 2)

HOW SUPPLIED

Baclofen Tablets, USP 10 mg are off-white, scored, oval-shaped tablets debossed “2265” on one side and debossed “V” on the reverse side; and supplied as follows:

  • Bottles of 15: NDC 33261-0010-15
  • Bottles of 30: NDC 33261-0010-30
  • Bottles of 45: NDC 33261-0010-45
  • Bottles of 60: NDC 33261-0010-60
  • Bottles of 90: NDC 33261-0010-90

Baclofen Tablets, USP 20 mg are off-white, scored, capsule-shaped tablets debossed “2266” on one side and debossed “V” on the reverse side; and are supplied as follows:

  • Bottles of 30: NDC 33261-0011-30
  • Bottles of 60: NDC 33261-0011-60
  • Bottles of 90: NDC 33261-0011-90

Dispense in a tight container with child-resistant closure.

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

Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811

Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880

8181162
R10/12-R4

PRINCIPAL DISPLAY PANEL

IMAGE LABEL
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PRINCIPAL DISPALY PANEL

IMAGE LABEL
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BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-010(NDC:0603-2406)
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
SILICON DIOXIDE
CROSPOVIDONE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
Product Characteristics
Color WHITE (off-white) Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code 2265;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33261-010-15 15 TABLET (15 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:33261-010-30 30 TABLET (30 TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:33261-010-45 45 TABLET (45 TABLET) in 1 BOTTLE, PLASTIC None
4 NDC:33261-010-60 60 TABLET (60 TABLET) in 1 BOTTLE, PLASTIC None
5 NDC:33261-010-90 90 TABLET (90 TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077156 08/30/2005
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:33261-011(NDC:0603-2407)
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
SILICON DIOXIDE
CROSPOVIDONE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
Product Characteristics
Color WHITE (off-white) Score 2 pieces
Shape OVAL (capsule-shaped) Size 16mm
Flavor Imprint Code 2266;V
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:33261-011-30 30 TABLET (30 TABLET) in 1 BOTTLE, PLASTIC None
2 NDC:33261-011-60 60 TABLET (60 TABLET) in 1 BOTTLE, PLASTIC None
3 NDC:33261-011-90 90 TABLET (90 TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077068 08/30/2005
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 12/2013 Aidarex Pharmaceuticals LLC

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