51128-501 : Montelukast 10 mg Oral Tablet, Film Coated

NDC:	51128-501
Labeler:	Kemwell Biopharma Private Limited
Product Type:	Human Prescription Drug
Drug Name:	Montelukast
Dosage Form:	Oral Tablet, Film Coated
Application #:	ANDA202859
Rev. Date:	Dec 1, 2014

Appearance:

Markings:	AUM101
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:

• 51128-501-01: 30 TABLET, FILM COATED IN 1 BOTTLE (51128‑501‑01)
• 51128-501-02: 90 TABLET, FILM COATED IN 1 BOTTLE (51128‑501‑02)
• 51128-501-03: 1000 TABLET, FILM COATED IN 1 BOTTLE (51128‑501‑03)

Active Ingredients:

• Montelukast Sodium

Inactive Ingredients:

• Cellulose, Microcrystalline
• Lactose Monohydrate
• Croscarmellose Sodium
• Hydroxypropyl Cellulose (Type H)
• Magnesium Stearate
• Hypromelloses
• Titanium Dioxide
• Ferric Oxide Red
• Ferric Oxide Yellow
• Carnauba Wax

Pharmaceutical Classes:

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

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