Baclofen (Page 2 of 2)

HOW SUPPLIED

Product: 50090-4682

NDC: 50090-4682-0 20 TABLET in a BOTTLE

NDC: 50090-4682-1 60 TABLET in a BOTTLE

NDC: 50090-4682-2 30 TABLET in a BOTTLE

NDC: 50090-4682-3 90 TABLET in a BOTTLE

Storage

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Manufactured by: Cadila Healthcare Ltd. India

Baclofen

Label ImageLabel Image
BACLOFEN
baclofen tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-4682(NDC:70710-1286)
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 DIBASIC CALCIUM PHOSPHATE
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
Product Characteristics
Color WHITE (white to off white) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code 1286
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-4682-0 20 TABLET in 1 BOTTLE None
2 NDC:50090-4682-1 60 TABLET in 1 BOTTLE None
3 NDC:50090-4682-2 30 TABLET in 1 BOTTLE None
4 NDC:50090-4682-3 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211659 12/06/2018
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-4682), REPACK (50090-4682)

Revised: 04/2021 A-S Medication Solutions

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