10135-639 : Levocetirizine Dihydrochloride 5 mg Oral Tablet, Film Coated

NDC:	10135-639
Labeler:	Marlex Pharmaceuticals Inc
Product Type:	Human Prescription Drug
Drug Name:	Levocetirizine Dihydrochloride
Dosage Form:	Oral Tablet, Film Coated
Application #:	ANDA202046
Rev. Date:	Sep 1, 2018

Appearance:

Markings:	I;12
Shapes:	Oval
Colors:	White
Size (mm):	8
Segments: *	2
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

• 10135-639-30: 30 TABLET, FILM COATED IN 1 BOTTLE (10135‑639‑30)
• 10135-639-90: 90 TABLET, FILM COATED IN 1 BOTTLE (10135‑639‑90)

Active Ingredients:

• Levocetirizine Dihydrochloride

Inactive Ingredients:

• Cellulose, Microcrystalline
• Lactose Monohydrate
• Silicon Dioxide
• Magnesium Stearate
• Hypromellose 2910 (5 Mpa.s)
• Titanium Dioxide
• Polyethylene Glycol 400 /

Pharmaceutical Classes:

• Histamine H1 Receptor Antagonists [MoA]
• Histamine-1 Receptor Antagonist [EPC]

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