58118-5560 : Montelukast 10 mg (As Montelukast Sodium 10.4 mg) Oral Tablet

NDC:	58118-5560
Labeler:	Clinical Solutions Wholesale
Product Type:	Human Prescription Drug
Drug Name:	Montelukast
Dosage Form:	Oral Tablet, Film Coated
Application #:	ANDA200889
Rev. Date:	Aug 3, 2012

Appearance:

Markings:	SZ;344
Shapes:	Round
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:

• 58118-5560-0: 1 TABLET, FILM COATED IN 1 PACKAGE (58118‑5560‑0)
• 58118-5560-3: 30 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (58118‑5560‑3)
• 58118-5560-8: 30 TABLET, FILM COATED IN 1 BLISTER PACK (58118‑5560‑8)
• 58118-5560-9: 90 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (58118‑5560‑9)

Active Ingredients:

• Montelukast Sodium

Inactive Ingredients:

• Croscarmellose Sodium
• Hydroxypropyl Cellulose
• Hypromelloses
• Lactose Monohydrate
• Magnesium Stearate
• Cellulose, Microcrystalline
• Polyethylene Glycols
• Ferric Oxide Red
• Titanium Dioxide
• Ferric Oxide Yellow

Pharmaceutical Classes:

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

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