54569-4605 : Singulair 10 mg Oral Tablet

NDC:	54569-4605
Labeler:	A-s Medication Solutions LLC
Product Type:	Human Prescription Drug
Drug Name:	Singulair
Dosage Form:	Oral Tablet, Film Coated
Application #:	NDA020829
Rev. Date:	Aug 12, 1998

Appearance:

Markings:	MRK;117;SINGULAIR
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:

• 54569-4605-0: 30 TABLET, FILM COATED IN 1 BOTTLE, DISPENSING (54569‑4605‑0)
• 54569-4605-1: 90 TABLET, FILM COATED IN 1 BOTTLE, DISPENSING (54569‑4605‑1)

Active Ingredients:

• Montelukast Sodium

Inactive Ingredients:

• Cellulose, Microcrystalline
• Lactose Monohydrate
• Croscarmellose Sodium
• Hydroxypropyl Cellulose
• Magnesium Stearate
• Hypromellose 2208 (15000 Cps)
• Titanium Dioxide
• Ferric Oxide Red
• Ferric Oxide Yellow
• Carnauba Wax

Pharmaceutical Classes:

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

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