BACLOFEN (Page 2 of 2)

HOW SUPPLIED

Baclofen Tablets USP, 10 mg are white to off-white, round, flat-faced, beveled-edge scored tablet debossed with “B” above score line and “10” below score line on one side and plain on other side. They are supplied as follows:

Bottles of 100 NDC 59651-394-01
Bottles of 500 NDC 59651-394-05
Bottles of 1,000 NDC 59651-394-99

Baclofen Tablets USP, 20 mg are white to off-white, round, flat-faced, beveled-edge scored tablet debossed with “B” above score line and “20” below score line on one side and plain on other side. They are supplied as follows:

Bottles of 100 NDC 59651-395-01
Bottles of 500 NDC 59651-395-05
Bottles of 1,000 NDC 59651-395-99

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required).
Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad–500 032, India
Revised: 10/2021

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg (100 Tablet Bottle)

NDC 59651-394-01
Rx only
Baclofen Tablets, USP
10 mg
AUROBINDO 100 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 10 mg (100 Tablet Bottle)
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 20 mg (100 Tablet Bottle)

NDC 59651-395-01
Rx only
Baclofen Tablets, USP
20 mg
AUROBINDO 100 Tablets

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -- 20 mg (100 Tablet Bottle)
(click image for full-size original)

BACLOFEN baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-394
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
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 112
STARCH, CORN
Product Characteristics
Color WHITE (White to off White) Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code B;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59651-394-01 100 TABLET in 1 BOTTLE None
2 NDC:59651-394-05 500 TABLET in 1 BOTTLE None
3 NDC:59651-394-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214099 07/13/2021
BACLOFEN baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:59651-395
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
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 112
STARCH, CORN
Product Characteristics
Color WHITE (White to off White) Score 2 pieces
Shape ROUND Size 11mm
Flavor Imprint Code B;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59651-395-01 100 TABLET in 1 BOTTLE None
2 NDC:59651-395-05 500 TABLET in 1 BOTTLE None
3 NDC:59651-395-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214099 07/13/2021
Labeler — Aurobindo Pharma Limited (650082092)
Establishment
Name Address ID/FEI Operations
APL HEALTHCARE LIMITED 650844777 ANALYSIS (59651-394), ANALYSIS (59651-395), MANUFACTURE (59651-394), MANUFACTURE (59651-395)

Revised: 11/2021 Aurobindo Pharma Limited

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