Acyclovir (Page 4 of 4)

Hemodialysis:

For patients who require hemodialysis, the mean plasma half-life of acyclovir during hemodialysis is approximately 5 hours. This results in a 60 % decrease in plasma concentrations following a 6-hour dialysis period. Therefore, the patient’s dosing schedule should be adjusted so that an additional dose is administered after each dialysis.

Peritoneal Dialysis:

No supplemental dose appears to be necessary after adjustment of the dosing interval.

HOW SUPPLIED

Acyclovir tablets, USP (white to off white, round) containing 400mg acyclovir, USP and engraved “S047” on one side and plain on the other side.

Bottle of 100 (69452-290-20)

Bottle of 500 (69452-290-30)

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from moisture.

Acyclovir tablets, USP (light blue, caplet) containing 800mg acyclovir, USP and engraved “S042” on one side and plain on the other side.

Bottle of 100 (69452-291-20)

Bottle of 500 (69452-291-30)

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] Protect from moisture.

To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma Inc. at 1-888-235-BION or 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Manufactured By: Distributed by:

Square Pharmaceuticals Ltd . Bionpharma Inc.

Dhaka Unit, Kaliakoir, Gazipur-1750, 600 Alexander Road, Princeton,

Bangladesh NJ 08540, USA

Mfg.Lic.No: 235 & 460

Rev.: June, 2020, V-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label – 400mg

Rx Only

NDC 69452-290-20

Acyclovir Tablets USP

400mg

100 Tablets

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).

[See USP Controlled Room Temperature.]

Protect from moisture.

Dispense in a tight container as defined in the USP.

See prescribing information for dosage information.

Acyclovir 400mg 100 Tablets
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label – 400mg

Rx Only

NDC 69452-290-30

Acyclovir Tablets USP

400mg

500 Tablets

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).

[See USP Controlled Room Temperature.]

Protect from moisture.

Dispense in a tight container as defined in the USP.

See prescribing information for dosage information.

Acyclovir 400mg 500 Tablets
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label – 800mg

Rx Only

NDC 69452-291-20

Acyclovir Tablets USP

800mg

100 Tablets

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).

[See USP Controlled Room Temperature.]

Protect from moisture.

Dispense in a tight container as defined in the USP.

See prescribing information for dosage information.

Acyclovir 800mg 100 Tablets
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label – 800mg

Rx Only

NDC 69452-291-30

Acyclovir Tablets USP

800mg

500 Tablets

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F).

[See USP Controlled Room Temperature.]

Protect from moisture.

Dispense in a tight container as defined in the USP.

See prescribing information for dosage information.

Acyclovir 800mg 500 Tablets
(click image for full-size original)
ACYCLOVIR acyclovir tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67296-2040(NDC:69452-290)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACYCLOVIR (ACYCLOVIR) ACYCLOVIR 400 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
POVIDONE K30
SODIUM STARCH GLYCOLATE TYPE A POTATO
MAGNESIUM STEARATE
Product Characteristics
Color white (White to off white) Score no score
Shape ROUND (flat faced beveled edge) Size 12mm
Flavor Imprint Code S047
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67296-2040-3 30 TABLET in 1 BOTTLE None
2 NDC:67296-2040-2 20 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209366 08/15/2020
Labeler — Redpharm drugs (828374897)
Establishment
Name Address ID/FEI Operations
Redpharm drug 828374897 repack (67296-2040)

Revised: 11/2023 Redpharm drugs

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