Montelukast Sodium (Page 8 of 8)

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Montelukast Sodium
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MONTELUKAST SODIUM montelukast sodium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-263(NDC:62175-210)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Montelukast Sodium (Montelukast) Montelukast 10 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide
croscarmellose sodium
hydroxypropyl cellulose (type h)
mannitol
cellulose, microcrystalline
polyethylene glycols
polyvinyl alcohol
sodium stearyl fumarate
talc
titanium dioxide
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 8mm
Flavor Imprint Code KU;210
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42254-263-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:42254-263-90 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201522 08/03/2012
Labeler — Rebel Distributors Corp (118802834)
Registrant — PSS World Medical, Inc. (101822862)
Establishment
Name Address ID/FEI Operations
PSS World Medical, Inc. 791528623 REPACK (42254-263)
Establishment
Name Address ID/FEI Operations
STAT RX USA LLC 786036330 REPACK (42254-263)
Establishment
Name Address ID/FEI Operations
Dispensing Solutions, Inc. 066070785 RELABEL (42254-263), REPACK (42254-263)
Establishment
Name Address ID/FEI Operations
SCRIPT PAK 964420108 RELABEL (42254-263), REPACK (42254-263)
Establishment
Name Address ID/FEI Operations
Keltman Pharmaceuticals, Inc. 362861077 REPACK (42254-263)
Establishment
Name Address ID/FEI Operations
Rebel Distirbutors Corp. 118802834 RELABEL (42254-263), REPACK (42254-263)

Revised: 07/2012 Rebel Distributors Corp

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