NDC Code(s) : 68788-0715-4
Packager : Preferred Pharmaceuticals, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AcyclovirAcyclovir SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-0715(NDC:50383-810)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACYCLOVIR(UNII: X4HES1O11F)
(ACYCLOVIR - UNII:X4HES1O11F) 		ACYCLOVIR200 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
BANANA(UNII: 4AJZ4765R9)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
GLYCERIN(UNII: PDC6A3C0OX)
METHYLPARABEN(UNII: A2I8C7HI9T)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
SORBITOL(UNII: 506T60A25R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68788-0715-4473 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077026 03/18/2011

PRINCIPAL DISPLAY PANEL

Acyclovir Oral Suspension USP 200mg/5mL

ACYCLOVIR ORAL SUSPENSION, USP

200 mg/5 mL

Each teaspoonful (5 mL) contains:

Acyclovir..............................................200 mg

Methylparaben..........................................0.1%

Propylparaben.........................................0.02%

(Added as preservatives)

USUAL DOSAGE: See package insert for dosage and full prescribing information.

Dispense in a tight container as defined in the USP. Store at 20 to 25°C (68 to 77°F). [see USP Controlled Room Temperature]. Protect from light.

Rx only

 

SHAKE WELL BEFORE USING

 

16 fl oz (473 mL)

 

HI-TECH PHARMACAL CO., INC.

Amityville, NY 11701

Relabeled By:

Preferred Pharmaceuticals, Inc

Anaheim, CA 92807
10/2012