NDC Code(s) : 69844-039-01, 69844-039-02, 69844-040-01, 69844-040-02
Packager : Graviti Pharmaceuticals Private Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

MONTELUKAST SODIUMMONTELUKAST SODIUM TABLET, CHEWABLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-039
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MONTELUKAST SODIUM(UNII: U1O3J18SFL)
(MONTELUKAST - UNII:MHM278SD3E) 		MONTELUKAST4 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FERRIC OXIDE RED(UNII: 1K09F3G675)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
Product Characteristics
Color PINK Score no score
Shape OVAL Size 11 mm
Flavor CHERRY Imprint Code OE;681
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69844-039-0130 in 1 BOTTLE Type 0: Not a Combination Product04/06/2020
2NDC:69844-039-02100 in 1 BOTTLE Type 0: Not a Combination Product04/06/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209011 04/06/2020
MONTELUKAST SODIUMMONTELUKAST SODIUM TABLET, CHEWABLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69844-040
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MONTELUKAST SODIUM(UNII: U1O3J18SFL)
(MONTELUKAST - UNII:MHM278SD3E) 		MONTELUKAST5 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FERRIC OXIDE RED(UNII: 1K09F3G675)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
Product Characteristics
Color PINK Score no score
Shape ROUND Size 10 mm
Flavor CHERRY Imprint Code OE;683
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69844-040-0130 in 1 BOTTLE Type 0: Not a Combination Product04/06/2020
2NDC:69844-040-02100 in 1 BOTTLE Type 0: Not a Combination Product04/06/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209011 04/06/2020

LABELER - Graviti Pharmaceuticals Private Limited(650884781)

REGISTRANT - Graviti Pharmaceuticals Private Limited(650884781)

Establishment
Name Address ID/FEI Business Operations
Graviti Pharmaceuticals Private Limited 650884781 MANUFACTURE(69844-039, 69844-040), ANALYSIS(69844-039, 69844-040)

PRINCIPAL DISPLAY PANEL

NDC 69844-039-01

Montelukast Sodium Chewable Tablets, USP

4 mg*

For Pediatric Patients 2 to 5 Years of Age

Phenylketonurics: contains phenylalanine (a component of aspartame) 0.38 mg per 4 mg chewable tablet.

Rx only

30 Tablets

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PRINCIPAL DISPLAY PANEL

NDC 69844-040-01

Montelukast Sodium Chewable Tablets, USP

5 mg*

For Pediatric Patients 6 to 14 Years of Age

For Pediatric Patients 6 to 14 Years of Age Phenylketonurics: contains phenylalanine (a component of aspartame) 0.47 mg per 5 mg chewable tablet.

Rx only

30 Tablets

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