Montelukast Sodium: Package Insert and Label Information (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 10 mg Label

NDC 16729- 119 -10

Montelukast Sodium Tablets, USP

10 mg For Adults 16 Years of Age and Older

Rx Only

Pharmacist: Dispense with attached Patient Information Leaflet.

30 Tablets

PRINCIPAL DISPLAY PANEL
(click image for full-size original)
MONTELUKAST SODIUM montelukast sodium tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16729-119
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
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (TYPE L)
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 6000
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color brown (beige) Score no score
Shape SQUARE (rounded square-shaped) Size 8mm
Flavor Imprint Code M10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16729-119-10 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:16729-119-15 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:16729-119-17 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202717 04/11/2013
Labeler — Accord Healthcare Inc. (604222237)
Establishment
Name Address ID/FEI Operations
Intas Pharmaceuticals Ltd 725927649 manufacture (16729-119), analysis (16729-119)
Establishment
Name Address ID/FEI Operations
Intas Pharmaceuticals Limited 915837971 manufacture (16729-119), analysis (16729-119)

Revised: 01/2022 Accord Healthcare Inc.

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