61919-009 : Montelukast Sodium 10 mg Oral Tablet, Film Coated

NDC:	61919-009
Labeler:	Direct Rx
Product Type:	Human Prescription Drug
Drug Name:	Montelukast Sodium
Dosage Form:	Oral Tablet, Film Coated
Application #:	ANDA202717
Rev. Date:	Jan 1, 2014

Appearance:

Markings:	M10
Shapes:	Square (4 sides)
Colors:	Brown
Size (mm):	8
Segments: *	1
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

• 61919-009-30: 30 TABLET, FILM COATED IN 1 BOTTLE (61919‑009‑30)
• 61919-009-90: 90 TABLET, FILM COATED IN 1 BOTTLE (61919‑009‑90)

Active Ingredients:

• Montelukast Sodium

Inactive Ingredients:

• Croscarmellose Sodium
• Hydroxypropyl Cellulose (Type L)
• Magnesium Stearate
• Hypromellose 2910 (6 Mpa.s)
• Titanium Dioxide
• Polyethylene Glycol 6000
• Ferric Oxide Red
• Ferric Oxide Yellow

Pharmaceutical Classes:

• Leukotriene Receptor Antagonist [EPC]
• Leukotriene Receptor Antagonists [MoA]

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