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.

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.

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.

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 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