Levocetirizine Dihydrochloride (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

NDC 68788-7699
Levocetirizine
Dihydrochloride
Tablets, USP
5 mg
For oral administration
Rx Only MICRO LABS LIMITED

Repackaged By: Preferred Pharmaceuticals Inc.

Levocetirizine Dihydrochloride Tablets 5mg
(click image for full-size original)
LEVOCETIRIZINE DIHYDROCHLORIDE levocetirizine dihydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-7699(NDC:42571-122)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE) LEVOCETIRIZINE DIHYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
SILICON DIOXIDE
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (5 MPA.S)
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
Product Characteristics
Color white (white to off white) Score 2 pieces
Shape OVAL (biconvex) Size 8mm
Flavor Imprint Code I12
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-7699-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68788-7699-6 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68788-7699-9 90 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:68788-7699-1 100 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202046 04/01/2020
Labeler — Preferred Pharmaceuticals, Inc. (791119022)
Registrant — Preferred Pharmaceuticals, Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc. 791119022 REPACK (68788-7699)

Revised: 07/2022 Preferred Pharmaceuticals, Inc.

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