Montelukast Sodium (Page 8 of 8)

Montelukast Sodium Chewable Tablets, 4 mg

0054-0288-13

0054-0288-13
(click image for full-size original)

Montelukast Sodium Chewable Tablets, 5 mg

0054-0289-13

0054-0289-13
(click image for full-size original)

Montelukast Sodium Tablets, 10 mg

0054-0259-13

0054-0259-13
(click image for full-size original)
MONTELUKAST SODIUM
montelukast sodium tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-0259
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
LACTOSE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
POLYETHYLENE GLYCOL 3350
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYVINYL ALCOHOL
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BROWN (light tan) Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 54;157
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0054-0259-13 30 TABLET in 1 BOTTLE None
2 NDC:0054-0259-22 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090655 08/03/2012
MONTELUKAST SODIUM
montelukast sodium tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-0288
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MONTELUKAST SODIUM (MONTELUKAST) MONTELUKAST 4 mg
Inactive Ingredients
Ingredient Name Strength
COPOVIDONE K25-31
FERRIC OXIDE RED
MAGNESIUM STEARATE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SUCRALOSE
Product Characteristics
Color PINK (speckled) Score no score
Shape OVAL Size 10mm
Flavor CHERRY Imprint Code 54;144
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0054-0288-13 30 TABLET, CHEWABLE in 1 BOTTLE None
2 NDC:0054-0288-22 90 TABLET, CHEWABLE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091128 08/03/2012
MONTELUKAST SODIUM
montelukast sodium tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0054-0289
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MONTELUKAST SODIUM (MONTELUKAST) MONTELUKAST 5 mg
Inactive Ingredients
Ingredient Name Strength
COPOVIDONE K25-31
FERRIC OXIDE RED
MAGNESIUM STEARATE
MANNITOL
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
SUCRALOSE
Product Characteristics
Color PINK (speckled) Score no score
Shape ROUND Size 9mm
Flavor CHERRY Imprint Code 54;741
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0054-0289-13 30 TABLET, CHEWABLE in 1 BOTTLE None
2 NDC:0054-0289-22 90 TABLET, CHEWABLE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091128 08/03/2012
Labeler — Roxane Laboratories, Inc. (833490464)
Registrant — Roxane Laboratories, Inc. (833490464)
Establishment
Name Address ID/FEI Operations
Boehringer Ingelheim Roxane, Inc. 058839929 MANUFACTURE (0054-0259), MANUFACTURE (0054-0288), MANUFACTURE (0054-0289)
Establishment
Name Address ID/FEI Operations
Teva API India Ltd. 677604388 API MANUFACTURE (0054-0288), API MANUFACTURE (0054-0289), API MANUFACTURE (0054-0259)
Establishment
Name Address ID/FEI Operations
Assia Chemical Industries Ltd. — Teva Tech Site 514678507 API MANUFACTURE (0054-0259)
Establishment
Name Address ID/FEI Operations
Abic Ltd. 600000301 API MANUFACTURE (0054-0259)

Revised: 01/2013 Roxane Laboratories, Inc.

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